NCT03427814

Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

Detailed description

This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status. Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met. After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.

Conditions

• Advanced or Inoperable Gastric Cancer

Interventions

Type	Name	Description
DRUG	Pamiparib	60 mg orally twice daily
DRUG	Placebo	60 mg orally twice daily

Timeline

• Start date: 2018-07-03
• Primary completion: 2020-06-18
• Completion: 2023-01-03
• First posted: 2018-02-09
• Last updated: 2024-10-26
• Results posted: 2023-09-21

Locations

65 sites across 16 countries: United States, Australia, Belgium, China, Czechia, France, Georgia, Hong Kong, Hungary, Japan, Poland, Russia, Singapore, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study