Conditions: Gastric Cancer
Keywords: Poly(ADP ribose) polymerase (PARP) Gastric cancer olaparib PARP inhibitor ATM AZD2281 Ku0059436 Homologous Recombination deficiency (HRD) Recurrent gastric cancer metastatic gastric cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

Brief summary:
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.

Detailed description:

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

Interventions: intervention 1: olaparib intervention 2: paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: 100mg BID oral tablet continuous intervention 2: iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle intervention 3: 100mg BID oral tablet to match olaparib tablet

Protocol document: