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Report for Clinical Trial NCT03166631
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The main objective of the dose-escalation parts of the trial is to determine the maximum
tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting
toxicities (DLTs), and/or the recommended dose for further development of BI 891065
monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety
and tolerability by monitoring the occurrence and severity of adverse events (AEs).
Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065
monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary
assessment of anti-tumour activity.
Name: BI 891065
Description: Part A, B & C
Type: Drug
Group Labels: 3 Part A Part B Part C
Name: BI 754091
Description: Part B & C
Type: Drug
Group Labels: 2 Part B Part C
Primary Outcomes
Measure: Part A - Maximum tolerated dose of BI 891065 Time: 9 months
Measure: Part A - number of patients with Dose-limiting toxicities (DLTs) during the first treatment cycle. Time: 3 weeks
Measure: Part B - Maximum tolerated dose of BI 891065 in combination with BI 754091 Time: 9 months
Measure: Part B - number of patients with Dose-limiting toxicities (DLTs) during the first treatment cycle. Time: 3 weeks
Measure: Part C - Objective response (OR) is defined as best overall response of Complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Time: 18 weeks
Secondary Outcomes
Measure: Part A - The number of patients with Dose-limiting toxicities (DLTs) observed during the entire treatment period. Time: 12 months
Measure: Part A - Cmax(,ss) of BI 891065 in the first treatment cycle. Time: 3 weeks
Measure: Part A - Objective response (OR) based on RECIST v1.1. Time: 12 months
Measure: Part B - The number of patients with Dose-limiting toxicities (DLTs) observed during the entire treatment period. Time: 12 months
Measure: Part B - Cmax(,ss) of BI 891065 Time: 3 weeks
Measure: Part B - Objective response (OR) based on RECIST v1.1. Time: 12 months
Measure: Part C - Duration of Objective response (OR) based on RECIST 1.1 (for the NSCLC cohort) Time: 18 months
Measure: Part A - AUC0-tz of BI 891065 in the first treatment cycle. Time: 3 weeks
Measure: Part A - AUC tau,ss of BI 891065 in the first treatment cycle. Time: 3 weeks
Measure: Part B - AUC0-tz of BI 891065 Time: 3 weeks
Measure: Part B - AUCtau,ss of BI 891065 Time: 3 weeks
Measure: Part B - Cmax of BI 754091 in the first treatment cycle. Time: 3 weeks
Measure: Part B - AUC0-tz of BI 754091 in the first treatment cycle. Time: 3 weeks
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 T790M
- For Parts A and B: Patients with known epidermal growth factor receptor (EGFR), known
anaplastic lymphoma kinase (ALK), or known ROS Proto-Oncogene 1 (ROS1) genomic tumour
aberrations, unless disease has progressed following available EGFR or ALK targeted
therapy (including osimertinib for EGFR T790M-mutated NSCLC)
- Out of range lab values as defined:
- Absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)
- Platelet (PLT) count <100 x 109/L
- Haemoglobin <90 g/L (<9 g/dL)
-- Creatinine >1.5 times ULN (patients may enter if creatinine is >1.5 x ULN and
estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 --- T790M ---