drugset
drugset / Trial / NCT02392676

Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations

NCT02392676 ↗

Phase 3 Withdrawn AstraZeneca Myriad Genetic Laboratories, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who have a complete or partial response to platinum-based chemotherapy.

Timeline

Start
2016-07
Primary completion
2019-06
Completion
2019-06

Outcome

Outcome not reported

Stopped: “Study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg Oral

Indications

No indication recorded.