Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With GOG Foundation, Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

450actual

Sites

177

Countries

Australia, Brazil, Canada +12

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

2013-08-26

actual

When the study began enrolling

Primary completion

2018-05-17

actual

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

Study completion

2028-08-29

estimated

The whole study's end, after follow-up

First posted

2013-05-03

estimated

When this record first appeared on the registry

Results posted

2019-07-09

actual

When the sponsor posted results to the registry

Record updated

2025-12-10

actual

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

What it studies

Conditions

Newly Diagnosed
Advanced Ovarian Cancer
FIGO Stage III-IV
BRCA Mutation
Complete Response
Partial Response
First Line Platinum Chemotherapy

Intervention

Drug: Olaparib 300mg tablets

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 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

Posted documents

hosted by the registry — we link, never re-serve

Study Protocolposted 2021-11-05 · 11.2 MB · Prot_002.pdf

Statistical Analysis Planposted 2022-02-15 · 3.4 MB · SAP_003.pdf

Publications

PMID 39695768 — linked by the registry
PMID 36082969 — linked by the registry
PMID 35170751 — linked by the registry
PMID 34715071 — linked by the registry
PMID 33862001 — linked by the registry
PMID 30345884 — 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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