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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03427814.
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.
Lead OrganizationBeiGene Company Limited