A Phase 2 interventional study of TAK-788 and Antidiarrheal prophylaxis in Non-Small Cell Lung Cancer (NSCLC), sponsored by Takeda. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Takeda · Phase 2, Interventional, and Prevention
The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations treated with TAK-788 when administered with or without intensive loperamide prophylaxis.
The drug being tested in this study is called TAK-788. TAK-788 administered with or without antidiarrheal prophylaxis is being tested to evaluate the impact of management strategies on gastrointestinal-related adverse events in participants with non-small cell lung cancer harboring EGFR Exon 20 insertion mutations receiving TAK-788.
The study will enroll approximately 90 patients. Participants will be randomly assigned in 1:1 ratio (by chance, like flipping a coin) to one of the two treatment groups-
All participants will be asked to take TAK-788 capsules with or without a low-fat meal in Cohort 1 and TAK-788 capsule with antidiarrheal prophylaxis and with or without a low-fat meal in Cohort 2.
This is a multi-center trial and will be conducted worldwide. The overall time to participate in this study is approximately 2 years. Participants will make multiple visits to the clinic after receiving their last dose of drug for a follow-up assessment.
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A documented epidermal growth factor receptor (EGFR) mutation with in-frame exon 20 insertion, confirmed as follows:
Note: A documented EGFR in-frame exon 20 insertion or insertion-duplication includes but is not limited to one of the following:
The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations. The reported insertion-duplication can have been detected on either tissue or liquid biopsy using a well-validated test based on either polymerase chain reaction, sequencing or next-generation sequencing (NGS).
Exclusion Criteria:
Has been diagnosed with another primary malignancy other than NSCLC, except for the following:
Has unstable brain metastases to include previously untreated intracranial central nervous system (CNS) metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.
Has an ongoing or active infection, to include but not limited to infections requiring intravenous antibiotics or has a known history of HIV. Testing for HIV is not required in the absence of history.
Note: Hepatitis B surface antigen-positive participants are allowed to enroll if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is below 1000 copies/mL in the plasma. Patients who are positive for anti-hepatitis C virus antibody can be enrolled but must not have detectable hepatitis C virus (HCV) RNA in the plasma.
TAK-788 160 mg, capsules, orally, once daily (QD) with or without a low-fat meal until disease progression or as assessed by the investigator during every 3-week cycle.
Drug: TAK-788
TAK-788 160 mg, capsules, orally, QD with or without a low-fat meal and antidiarrheal prophylaxis administered during the first 8 weeks of treatment until disease progression or as assessed by the investigator during every 3-week cycle.
Drug: TAK-788 · Drug: Antidiarrheal prophylaxis
TAK-788 capsules
Also known as: AP32788, Mobocertinib
Antidiarrheal prophylaxis includes loperamide tablet administered as per routine clinical practice.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) of ≥Grade 3 Diarrhea Occurring During the First 4 Cycles of TAK-788 Dosing
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Grading will be done using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria. Per NCI CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Time frame: Approximately 15 Months
Number of Participants with TEAEs of ≥Grade 3 Nausea and Vomiting Occurring During the First 4 Cycles of TAK-788 Dosing
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Grading will be done using the NCI-CTCAE criteria. Per NCI CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Time frame: Approximately 15 Months
Number of Participants With TEAEs of Diarrhea, Nausea, Vomiting and Other Adverse Event of Clinical Interest (AECIs) Occurring During the First 4 Cycles of TAK-788 Dosing
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Approximately 15 Months
Overall Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR will be defined as the percentage of participants achieving complete response (CR) or partial response (PR). CR is defined as disappearance of all extranodal target lesions. PR is defined as at least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD.
Time frame: Approximately 15 Months
Duration of Response as per RECIST Version 1.1
DOR will be defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that PD is objectively documented. CR is defined as disappearance of all extranodal target lesions. PR is defined at least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD. PD is defined as at least a 20% increase in the Sum of Diameters (SoD) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.
Time frame: Approximately 15 Months
Progression Free Survival (PFS) as per RECIST Version 1.1
PFS will be defined as the interval from the randomization date until the first date at which the criteria for disease progression according to RECIST version 1.1 are met or death. PD is defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.
Time frame: Approximately 15 Months
Health-Related Quality of Life (HRQoL) as Assessed European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Score
The EORTC QLQ-C30 is a cancer-specific questionnaire tested in participants with lung cancer. The EORTC QLQ-C30 will be scored for 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL.
Time frame: Approximately 15 Months
Health-Related Quality of Life (HRQoL) as Assessed by EORTC Lung Cancer Module (QLQ-LC13) Score
The EORTC QLQ-LC13 module will comprise 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. The LC13 module incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis. Raw scores are converted into scale scores ranging from 0 to 100, where the higher scores represent worse symptoms and lower scores represent better HRQoL.
Time frame: Approximately 15 Months
Health-Related Quality of Life (HRQoL) as Assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score
The NSCLC-SAQ is qualified by the US Food and Drug Administration (FDA) to measure symptoms of NSCLC. The NSCLC-SAQ has 7 items with 5-level verbal rating scale and measures the severity/frequency of the following NSCLC symptoms: cough, pain, dyspnea, fatigue, and appetite. The raw scores are ranged from 0 to 4 and total score is ranged from 0-20.
Time frame: Approximately 15 Months
No study locations are listed for this record.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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