A Phase 1/2 interventional study of Poziotinib Once Daily Dosing and Poziotinib Twice Daily Dosing in NSCLC, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 3 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · Phase 1/2, Interventional, and Treatment
A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
This is a Phase 1/2, open-label, multicenter study in Japanese patients with locally advanced or metastatic NSCLC. This study will be conducted in two parts. Phase 1 is designed to observe the maximum tolerated dose (MTD) or maximum administered dose (MAD) of poziotinib when administered once daily or twice daily. Phase 2 will evaluate the safety and efficacy of the dose determined in Phase 1. Study participation includes a 30 day screening period, up to 24 months of treatment, and long-term follow-up for a maximum of 24 months after discontinuation of study treatment.
Phase 1 will enroll up to 36 patients into a dose finding study with two parallel, randomized dose groups. Each group will undergo a dose-finding scheme using a 3+3 design with the assessment of dose-limiting toxicities (DLTs) at up to three dose levels. Patients will be randomized into once daily (QD) or twice daily (BID) dose groups. The DLT assessment will be conducted in the first cycle of treatment and therefore, poziotinib dose modifications are not permitted during this cycle. Patients will be hospitalized for the first 2 weeks.
Phase 2 will enroll 40 additional NSCLC patients with epidermal growth factor receptor (EGFR) (20 patients) or human epidermal growth factor 2 (HER2) (20 patients) exon 20 insertion mutations. Efficacy and safety of the dose and dosing regimen determined in Phase 1 will be evaluated. All patients will be treated in 28-day cycles for up to 24 months.
Spectrum Pharmaceuticals, Inc is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
First submitted before Spectrum Pharmaceuticals, Inc became part of Zydus Lifesciences Limited.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Previously treated patient with or cytologically confirmed ( accepted) locally advanced or non-small cell lung cancer (NSCLC) and is not a candidate for definitive therapy
Prior treatment status:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose finding at 8 mg, 12 mg, or 16 mg of poziotinib once daily in 28-day treatment cycles.
Drug: Poziotinib Once Daily Dosing
Dose finding at 4 mg, 6 mg, or 8 mg of poziotinib twice daily in 28-day treatment cycles.
Drug: Poziotinib Twice Daily Dosing
Once Daily or Twice Daily Dosing as determined in Phase 1 in 28-day treatment cycles. Cohort 1: EGFR exon 20 insertion mutations Cohort 2: HER2 exon 20 insertion mutations
Drug: Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of \>38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion.
Time frame: Cycle 1 (Day 1-28)
Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with best response i.e confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time frame: Up to 461 days
Phase 2: Disease Control Rate (DCR)
The percentage of participants who achieve CR, PR, and stable disease (SD) by the best response from the first dose of poziotinib to the end of the study as assessed by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Time frame: Up to 461 days
Phase 2: Duration of Response (DoR)
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease as assessed by the investigator according to RECIST v1.1 or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Time frame: Up to 461 days
Phase 2: Progression Free Survival (PFS)
PFS was the number of days from the treatment start date to the date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in sum of diameters (SOD) from previous smallest SOD on study, and an absolute increase of ≥5mm.
Time frame: Up to 461 days
Phase 1: Plasma Concentration of Poziotinib and M1, M2 Metabolites
Time frame: Cycle 1, Day 1 and Day 13
Phase 1 and 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAE)
TEAEs are AEs that occur from the first dose of study treatment until 40 days after the last dose of study treatment. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time frame: Up to 40 days after the last dose of the study drug (Up to 461 days)
Phase 2: Exploratory - Overall Survival
The number of days from the treatment start date to the date of death due to any cause.
Time frame: 2 years
A total of 42 participants were enrolled at multiple investigative sites in Japan from 23 Jun 2020 to 15 Feb 2023.
| Milestone | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1: Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD |
|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 4 | 6 | 3 | 20 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 3 | 3 | 4 | 6 | 3 | 20 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Disease progression | 3 | 2 | 3 | 3 | 4 | 3 | 10 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Sponsor decision | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of \>38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion.
| Participants | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1: Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID |
|---|---|---|---|---|---|---|
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 | 3 | 0 | 1 | 2 |
ORR was defined as the percentage of participants with best response i.e confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
No measurements were reported for this outcome.
The percentage of participants who achieve CR, PR, and stable disease (SD) by the best response from the first dose of poziotinib to the end of the study as assessed by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
No measurements were reported for this outcome.
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease as assessed by the investigator according to RECIST v1.1 or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
No measurements were reported for this outcome.
PFS was the number of days from the treatment start date to the date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in sum of diameters (SOD) from previous smallest SOD on study, and an absolute increase of ≥5mm.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
TEAEs are AEs that occur from the first dose of study treatment until 40 days after the last dose of study treatment. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
| percentage of participants | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1: Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD |
|---|---|---|---|---|---|---|---|
| Phase 1 and 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAE) | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
The number of days from the treatment start date to the date of death due to any cause.
Results for this outcome have not been posted.
Collected over Up to 40 days after the last dose of the study drug (Up to 461 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: Poziotinib 8 mg QD | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1: Poziotinib 12 mg QD | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| Phase 1: Poziotinib 16 mg QD | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| Phase 1: Poziotinib 4 mg BID | 3/4 (75%) | 1/4 (25%) | 4/4 (100%) |
| Phase 1: Poziotinib 6 mg BID | 2/6 (33.3%) | 1/6 (16.7%) | 6/6 (100%) |
| Phase 1: Poziotinib 8 mg BID | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Phase 2: Poziotinib 12mg QD | 5/20 (25%) | 4/20 (20%) | 20/20 (100%) |
| Event | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1: Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12mg QD |
|---|---|---|---|---|---|---|---|
| SeizureNervous system disorders | 1/3 | 0/3 | 0/3 | 0/4 | 0/6 | 0/3 | 0/20 |
| Amylase increasedInvestigations | 0/3 | 0/3 | 0/3 | 1/4 | 0/6 | 0/3 | 0/20 |
| EpilepsyNervous system disorders | 0/3 | 0/3 | 0/3 | 0/4 | 1/6 | 0/3 | 0/20 |
| AnaemiaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/3 | 0/4 | 0/6 | 0/3 | 1/20 |
| ConstipationGastrointestinal disorders | 0/3 | 0/3 | 0/3 | 0/4 | 0/6 | 0/3 | 1/20 |
| UrethritisRenal and urinary disorders | 0/3 | 0/3 | 0/3 | 0/4 | 0/6 | 0/3 | 1/20 |
| Urinary tract infectionInfections and infestations | 0/3 | 0/3 | 0/3 | 0/4 | 0/6 | 0/3 | 1/20 |
| Event | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1: Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12mg QD |
|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/3 | 3/3 | 2/3 | 2/4 | 5/6 | 3/3 | 17/20 |
| StomatitisGastrointestinal disorders | 1/3 | 3/3 | 3/3 | 2/4 | 4/6 | 3/3 | 11/20 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 2/3 | 2/3 | 3/3 | 3/4 | 4/6 | 0/3 | 10/20 |
| RashSkin and subcutaneous tissue disorders | 1/3 | 1/3 | 1/3 | 0/4 | 0/6 | 3/3 | 7/20 |
| ParonychiaInfections and infestations | 1/3 | 2/3 | 1/3 | 3/4 | 3/6 | 2/3 | 14/20 |
| Skin fissuresSkin and subcutaneous tissue disorders | 1/3 | 0/3 | 0/3 | 3/4 | 2/6 | 0/3 | 2/20 |
| Dry skinSkin and subcutaneous tissue disorders | 1/3 | 2/3 | 0/3 | 2/4 | 1/6 | 2/3 | 5/20 |
| AlopeciaSkin and subcutaneous tissue disorders | 0/3 | 2/3 | 1/3 | 0/4 | 0/6 | 0/3 | 4/20 |
| Angular CheilitisGastrointestinal disorders | 1/3 | 1/3 | 0/3 | 2/4 | 1/6 | 0/3 | 2/20 |
| MalaiseGeneral disorders | 1/3 | 0/3 | 0/3 | 2/4 | 0/6 | 0/3 | 3/20 |
Safety population included all participants who signed informed consent, enrolled and received at least 1 dose of poziotinib.
| Age, Continuous(years) | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1:Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 61.7 ± 15.01 | 58.7 ± 12.86 | 65.3 ± 17.79 | 57.8 ± 15.26 | 60.3 ± 15.58 | 52.0 ± 20.07 | 60.9 ± 10.36 | 60.1 ± 12.59 |
| Sex: Female, Male(Participants) | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1:Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 1 | 2 | 3 | 14 | 22 |
| Male | 3 | 2 | 2 | 3 | 4 | 0 | 6 | 20 |
| Race (NIH/OMB)(Participants) | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1:Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 3 | 3 | 4 | 6 | 3 | 20 | 42 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 00 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Phase 1: Poziotinib 8 mg QD | Phase 1: Poziotinib 12 mg QD | Phase 1: Poziotinib 16 mg QD | Phase 1:Poziotinib 4 mg BID | Phase 1: Poziotinib 6 mg BID | Phase 1: Poziotinib 8 mg BID | Phase 2: Poziotinib 12 mg QD | Total |
|---|---|---|---|---|---|---|---|---|
| Ethnicity — Hispanic/ Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity — Not Hispanic/ Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity — Japanese | 3 | 3 | 3 | 4 | 6 | 3 | 20 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2020 to primary completion in Feb 2023, 31 months.
Results were first posted in Jun 2024, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Spectrum Pharmaceuticals, Inc →