SNPMiner Trials (Home Page)
Report for Mutation L861R
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
The purpose of this phase 1/2 study is to evaluate the safety, recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics of oral TAK-788, anti-tumor activity of TAK-788 in participants with NSCLC with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations, and to explore relationship between tumor and/or plasma biomarkers, and TAK-788 efficacy, safety, and/or cytochrome P450 3A (CYP3A) induction. The study will also determine the efficacy of TAK-788 in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.
NCT02716116 Carcinoma, Non-Small-Cell Lung Drug: TAK-788 MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma
Part 2: Expansion Cohort 4 Specific Inclusion Criteria: 1. Have one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutation other than exon 20 insertion including, but not limited to, G719X (where X is any other amino acid), S768I, L861Q, or L861R. --- L858R --- --- T790M --- --- S768I --- --- L861Q --- --- L861R ---
Primary Outcomes
Measure: Dose Escalation Cohort: RP2D of Orally Administered TAK-788 Time: Day 1 to 28 (Cycle 1)Measure: Expansion Cohorts 1, 2, 4, 5 and 7: Confirmed Objective Response Rate (ORR) Assessed by the Investigator Time: up to 36 months after first dose
Measure: Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC) Time: up to 36 months after first dose
Measure: Extension Cohort: Confirmed ORR Assessed by IRC Time: up to 36 months after first dose
Measure: Expansion Cohort 6: Confirmed ORR Assessed by IRC Time: up to 36 months after first dose
Secondary Outcomes
Measure: Dose Escalation and Expansion Cohorts: Safety Analysis of TAK-788 Assessed by Adverse Events, Toxicity Grades, and Laboratory Test Results Time: up to 36 months after first doseMeasure: Dose Escalation Cohort: Identify DLTs and MTD of TAK-788 Time: Day 1 to 28 in Cycle 1 (Cycle length is equal to [=] 28 days)
Measure: Dose Escalation and Expansion Cohorts: Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: AUC 24: Area Under the Concentration-time Curve from Time Zero to 24 hours for TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: AUCt: Area Under the Concentration-time Curve from Time Zero to Time t for TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: RAC (Cmax): Accumulation Ratio Based on Cmax of TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: Ctrough: Observed Concentration at the end of a Dosing Interval of TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: RAC (AUC): Accumulation Ratio Based on AUC of TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: Cmax: Maximum Observed Concentration of TAK-788 and its Metabolites Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Expansion Cohorts 1, 2, 3, 4, 5, and 7: Confirmed ORR as Assessed by IRC Time: up to 36 months after first dose
Measure: Expansion Cohorts: Best Overall Response as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion Cohorts: Best Target Lesion Response as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion and Extension Cohorts: Duration of Response as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion and Extension Cohorts: Time to Response as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion Cohort 3: Duration of Intracranial Response (iDOR) Time: up to 36 months after first dose
Measure: Expansion and Extension Cohorts: Disease Control Rate (DCR) as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion and Extension Cohorts: Progression Free Survival (PFS) as Assessed by the Investigator and IRC Time: up to 36 months after first dose
Measure: Expansion Cohort 3: Intracranial PFS (iPFS) Time: up to 36 months after first dose
Measure: Expansion and Extension Cohorts: Overall Survival (OS) Time: up to 36 months after first dose
Measure: Extension Cohort: Confirmed ORR as Assessed by the Investigator Time: up to 36 months after first dose
Measure: Dose Escalation and Expansion Cohorts: Cmax: Dose Linearity for TAK-788 Exposure Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Dose Escalation and Expansion Cohorts: AUC: Dose Linearity for TAK-788 Exposure Time: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days)
Measure: Number of Participants With Patient-reported Symptoms (Lung Cancer), Functioning, and Health-related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30) Time: up to 30 days after last dose of drug (approximately up to 37 months)
Measure: Number of Participants With Patient-reported Symptoms (Lung Cancer), Functioning, and health-related Global Quality of Life (HRQoL) Based on Quality of Life Questionnaire Lung Cancer Module-13 (QLQ-LC13) Time: up to 30 days after last dose of drug (approximately up to 37 months)
Measure: Expansion Cohorts 6: Confirmed ORR as Assessed by the Investigator Time: up to 36 months after first dose
2 A Phase 1 Study of BPI-15086 in Patients With Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed on Previous EGFR Tyrosine Kinase Inhibitor Therapy
The main objective of this study is to evaluate the safety and tolerability of BPI-15086.
NCT02914990 Non-Small Cell Lung Cancer Drug: BPI-15086 MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
icotinib, gefitinib, afatinib, neratinib, dacomitnib, or erlotinib) treatment - Patients must fulfil one of the following: - Confirmation that the tumour harbours EGFR sensitivity mutation (exon 19 deletion, L858R and L861R, G719X) - Must have experienced clinical benefit from EGFR TKIs, according to the Jackman criteria - Confirmation of T790M mutation positive after disease progression on EGFR TKIs - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and estimated life expectancy of at least 12 weeks - Measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST1.1) --- L858R --- --- L861R ---
Primary Outcomes
Description: Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Measure: Adverse events Time: 18 monthsSecondary Outcomes
Measure: Cmax Time: 4 weeksMeasure: Half life Time: 4 weeks
Measure: AUC Time: 4 weeks
Measure: Objective Response Rate Time: 12 weeks
Measure: Progression-Free Survival Time: 18 months