drugset / Trial / NCT03427814

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

NCT03427814 ↗

Phase 2 Completed 136 enrolled BeiGene
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-07-03
Primary completion
2020-06-18
Completion
2023-01-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Pamiparib vs Placebo; p = 0.1428; Log Rank NCT03427814 ↗

release “Pamiparib showed numerically higher progression-free survival in patients with gastric cancer compared to placebo, although the results did not achieve statistical significance” beonemedicines.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamiparib Small molecule 60 mg Oral

Indications