SNPMiner Trials by Shray Alag


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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 dose

Measure: 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 months

Secondary Outcomes

Measure: Cmax

Time: 4 weeks

Measure: Half life

Time: 4 weeks

Measure: AUC

Time: 4 weeks

Measure: Objective Response Rate

Time: 12 weeks

Measure: Progression-Free Survival

Time: 18 months


HPO Nodes