Conditions: Gastric Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 525
Healthy volunteers: no

Brief summary:
This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

Detailed description:
A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.

Arms:
arm 1: olaparib + paclitaxel arm 2: placebo+ paclitaxel

Interventions: intervention 1: Olaparib intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily. intervention 2: IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule. intervention 3: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Protocol document: