BGB-290 versus Placebo in Subjects with Inoperable Gastric Cancer
Research type
Research Study
Full title
A Phase 3, Double-blind, Randomised 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.
IRAS ID
239801
Contact name
Nicola Turvey
Contact email
Sponsor organisation
BeiGene Ltd. c/o BeiGene USA, Inc.
Eudract number
2017-003493-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 28 days
Research summary
This study is being carried out to evaluate if BGB-290 (an investigational drug) can increase the time period that the patient’s cancer responds to treatment and does not progress. Another purpose is to evaluate if the BGB-290 increases a person’s life span.
BGB-290 is an inhibitor of PARP1 and PARP2. PARP inhibitors are a group of inhibitors of the enzyme poly ADP ribose polymerase, which are developed for the treatment of cancer. PARP inhibitors are particularly effective in tumours that have defects in DNA repair.
Patients in this study will be assigned to either of the following 2 groups;
ARM A; BGB-290 60mg
ARM B; Placebo 60mgPatients will be randomised (assigned by chance, like flipping a coin) to either Arm A or Arm B. Neither the patient or study doctor will know which treatment they have been assigned.
• There are up to 4 phases for participants in this study
• Screening (to determine if participants qualify for the study)
• Treatment (the period patients are receiving study drug treatment)
• Safety Follow Up (a visit within 30 days after stopping study drug treatment)
• Long Term Follow UpApproximately 540 patients all over the world will take part in the study. This study is being sponsored by BeiGene, Ltd.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0122
Date of REC Opinion
24 May 2018
REC opinion
Further Information Favourable Opinion