Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

327actual

Sites

126

Countries

Australia, Belgium, Brazil +14

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2013-09-03

actual

When the study began enrolling

Primary completion

2016-09-19

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-12-31

estimated

The whole study's end, after follow-up

First posted

2013-06-11

estimated

When this record first appeared on the registry

Results posted

2018-02-07

actual

When the sponsor posted results to the registry

Record updated

2026-07-29

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Platinum Sensitive
BRCA Mutated
Relapsed Ovarian Cancer
Following Complete or Partial Response to Platinum Based Chemotherapy

Interventions

Drug: Olaparib 300mg tablets
Drug: Placebo to match olaparib 300mg

Primary outcome

what the primary-completion date above is the date OF

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)

measured Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.

Publications

PMID 41861615 — linked by the registry
PMID 39695768 — linked by the registry
PMID 35772665 — linked by the registry
PMID 35170751 — linked by the registry
PMID 33743851 — linked by the registry
PMID 32977221 — linked by the registry
PMID 30026002 — linked by the registry
PMID 28754483 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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