NCT02478866

Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors

Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors: A Phase Ia Study, Open-label, Dose-escalation Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of BPI-9016M with single doses and multiple doses.

Detailed description

This is a phase Ia study, first-in-human, open-label, dose-escalation study of BPI-9016M administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors.The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-9016M. All patients will be followed up for adverse events during the study treatment and 28 days after the last dose of study drug. Subjects of this study will be permitted to continue therapy only when BPI-9016M is well tolerated, and tumor response or stable disease is seen.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	BPI-9016M	Seven dose cohorts will be evaluated, including 100mg, 200mg, 300mg, 450mg，600mg, 800mg, 1000mg. BPI-9016M will be administered orally to patients once daily for each dose cohort.

Timeline

• Start date: 2015-08-11
• Primary completion: 2017-06-30
• Completion: 2017-11-01
• First posted: 2015-06-23
• Last updated: 2021-09-16

Locations

2 sites across 1 country: China