A Phase 2 interventional study of Monoclonal antibody Hu3S193 in Fallopian Tube Cancer, Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Recepta Biopharma. Terminated at 8 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Recepta Biopharma · Phase 2, Interventional, and Treatment
RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 29 is below the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →Recepta Biopharma is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Results of laboratorial exams in the first 2 weeks before drug infusion within the following values:
Exclusion Criteria:
Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Biological: Monoclonal antibody Hu3S193
30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Time frame: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.
1-year Disease Progression-free Survival Rate
Time frame: 1 year from the beginning of platinum-based rescue chemotherapy start date
Two-year Overall Survival Rate
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time frame: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Safety - Vital Signs - Heart Rate
Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Time frame: Baseline, week 2 , week 4 and week 27
Safety - Vital Signs - Respiratory Rate
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time frame: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time frame: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Temperature
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time frame: Baseline, week 2, week 4 and week 27
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Nervous System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Investigations
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)
The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From the first infusion of medication to 30 days after the last one
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)
Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
Time frame: Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9
Two-year Overall Survival: Median Time to Death
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time frame: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
This was a Brazilian, multicentric clinical trial. From April 12, 2011 to October 31, 2013 a total of 37 patients were screened for this study, of whom 29 received at least one dose of the investigational product and 07 were considered noneligible.
| Milestone | hu3S193 |
|---|---|
| Started | 29 |
| Completed | 15 |
| Not completed | 14 |
| Withdrew: Disease progression | 11 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Wrongly included | 1 |
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
| Months | hu3S193 |
|---|---|
| 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy | 11.7614 (10.5902 to 13.9251) |
| percentage of participants | hu3S193 |
|---|---|
| 1-year Disease Progression-free Survival Rate | 48.2 |
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
| percentage of participants | hu3S193 |
|---|---|
| Two-year Overall Survival Rate | 70.7 |
Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
| bpm | hu3S193 |
|---|---|
| Baseline | 78.00 ± 12.11 |
| Week 2 | 80.00 ± 11.49 |
| Week 4 | 76.00 ± 10.58 |
| Week 27 | 75.00 ± 9.84 |
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
| ipm (Incursions per minute) | hu3S193 |
|---|---|
| Baseline | 19.00 ± 2.10 |
| Week 2 | 19.00 ± 1.62 |
| Week 4 | 19.00 ± 1.59 |
| Week 27 | 19.00 ± 1.86 |
Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
| mmHg | hu3S193 |
|---|---|
| Diastolic Baseline | 80.00 ± 8.88 |
| Diastolic Week 2 | 77.00 ± 9.04 |
| Diastolic Week 4 | 70.00 ± 7.92 |
| Diastolic Week 27 | 80.00 ± 8.63 |
| Systolic Baseline | 115.00 ± 15.93 |
| Systolic Week 2 | 110.00 ± 14.79 |
| Systolic Week 4 | 118.00 ± 11.32 |
| Systolic Week 27 | 120.00 ± 13.00 |
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
| °C | hu3S193 |
|---|---|
| Baseline | 36.00 ± 0.41 |
| Week 2 | 36.00 ± 0.50 |
| Week 4 | 35.90 ± 0.43 |
| Week 27 | 35.70 ± 0.51 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Nausea | 19 |
| Vomiting | 17 |
| Abdominal pain | 9 |
| Constipation | 7 |
| Diarrhoea | 6 |
| Abdominal pain upper | 3 |
| Dry Mouth | 2 |
| Dyspepsia | 2 |
| Abdominal pain lower | 1 |
| Intestinal Obstruction | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Influenza like illness | 8 |
| Fatigue | 3 |
| Pain | 2 |
| Pyrexia | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Myalgia | 4 |
| Back pain | 3 |
| Pain in extremity | 2 |
| Arthralgia | 1 |
| Groin pain | 1 |
| Knee pain | 1 |
| Muscle tightness | 1 |
| Musculoskeletal pain | 10 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Hypersensitivity | 9 |
| Drug Hypersensitivity | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Headache | 9 |
| Paraesthesia | 1 |
| Peripheral sensory neuropathy | 1 |
| Tremor | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Neutrophil count decreased | 5 |
| White blood cell count decreased | 3 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Cough | 6 |
| Productive Cough | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Oral Herpes | 2 |
| Clostridium difficile colitis | 1 |
| Gastroenteritis | 1 |
| Tooth abscess | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia) | 4 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Sinusitis | 2 |
| Respiratory tract infection | 1 |
| Tonsillitis | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety) | 4 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Hypertension | 2 |
| Hyperaemia | 1 |
| Hypotension | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain) | 3 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills) | 3 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Erythema | 2 |
| Pruritus | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Cerumen impaction | 1 |
| Ear pain | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Bronchospasm | 1 |
| Rhinitis allergic | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Hip fracture | 1 |
| Upper limb fracture | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea) | 2 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Excoriation | 1 |
| Injection site erythema | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation) | 1 |
The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids) | 1 |
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
| Incidence | hu3S193 |
|---|---|
| Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis) | 1 |
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
| Incidence | Monoclonal Antibody hu3S193 |
|---|---|
| Intestinal obstruction | 1 |
| Vomiting | 1 |
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
| Incidence | Monoclonal Antibody hu3S193 |
|---|---|
| Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture | 1 |
Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
| (µg/mL) | Pharmacokinetic |
|---|---|
| Cmin | 2.14 ± 0.92 |
| Cmax | 18.32 ± 5.66 |
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
| months | hu3S193 |
|---|---|
| Two-year Overall Survival: Median Time to Death | 25.1 (16.7 to 32.4) |
Collected over They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| hu3S193 | — | 3/29 (10.3%) | 28/29 (96.6%) |
| Event | hu3S193 |
|---|---|
| Intestinal obstructionGastrointestinal disorders | 1/29 |
| VomitingGastrointestinal disorders | 1/29 |
| Hip fractureMusculoskeletal and connective tissue disorders | 1/29 |
| Event | hu3S193 |
|---|---|
| NauseaGastrointestinal disorders | 19/29 |
| VomitingGastrointestinal disorders | 17/29 |
| Abdominal painGastrointestinal disorders | 9/29 |
| HypersensitivityImmune system disorders | 9/29 |
| HeadacheNervous system disorders | 9/29 |
| Influenza like illnessGeneral disorders | 8/29 |
| ConstipationGastrointestinal disorders | 7/29 |
| DiarrhoeaGastrointestinal disorders | 6/29 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/29 |
| Neutrophil count decreasedInvestigations | 5/29 |
A total of 37 patients were screened for this study of whom 29 were considered eligible and included in the study (baseline participants).
| Age, Continuous(Years) | Monoclonal Antibody hu3S193 |
|---|---|
| Mean | 55.69 (29 to 67) |
| Gender(Participants) | Monoclonal Antibody hu3S193 |
|---|---|
| Female | 29 |
| Male | 0 |
| Race/Ethnicity, Customized(participants) | Monoclonal Antibody hu3S193 |
|---|---|
| White | 24 |
| Black | 1 |
| Yellow | 0 |
| Brown | 4 |
| Other | 0 |
| Region of Enrollment(participants) | Monoclonal Antibody hu3S193 |
|---|---|
| Brazil | 29 |
Plan to share: No — Recepta Biopharma understands the importance of individual-patient data (IPD) sharing and will include it in its future clinical studies; however, as this clinical study initiated in Apr-2011, an IPD was not planned.
This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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