NCT02929290

Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC. Biomarkers related to the efficacy of BPI-9016M will be investigated.

Detailed description

This study was a multicenter, open, single-arm, Ib-stage expanded clinical study. Part I：On the basis of Ia-stage dose escalation study, a safe and effective dose of -300 mg, 450 mg, 600 mg and 800 mg was selected to enlarge the enrollment study in patients with c-Met-dysregulated advanced NSCLC, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M. Part II：On the basis of the completed research results of Ia stage and part I, a safe and effective dose of 400 mg twice a day (bid) was selected to conduct an expanded enrollment study in NSCLC patients with MET exon 14 skipping alterations, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BPI-9016M	Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day.

Timeline

• Start date: 2017-03-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2016-10-11
• Last updated: 2021-09-13

Locations

7 sites across 1 country: China