NCT02914990

Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the safety and tolerability of BPI-15086.

Detailed description

The main objective of this study is to evaluate the safety and tolerability of BPI-15086. In addition, the anti-cancer effect of BPI-15086 in EGFR T790M mutation-positive advanced NSCLC patients who have progressed on a previous EGFR tyrosine kinase inhibitor therapy will also be evaluated. Biomarkers related to the efficacy of BPI-15086 will be investigated.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BPI-15086	BPI-15086 is administered once daily with a starting dose of 25 mg in a 21-day cycle. When tolerated, increasing doses of BPI-15086 will be tested in subsequent cohorts, until a maximum tolerated dose is determined.

Timeline

• Start date: 2016-12-29
• Primary completion: 2019-03-07
• Completion: 2019-03-07
• First posted: 2016-09-26
• Last updated: 2019-07-18

Locations

1 site across 1 country: China