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

NCT01844986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-12-10

Study results available
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Summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Conditions

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

Interventions

DRUG

Olaparib 300mg tablets

Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Sponsors & Collaborators

Principal Investigators

  • Prof Paul DiSilvestro, MD · Women & Infants Hospital, Providence, Rhode Island, USA

  • Prof Kathleen Moore, MD · University of Oklahoma Health Sciences Center, Oklahoma City, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-26
Primary Completion
2018-05-17
Completion
2028-08-29

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • France
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01844986 on ClinicalTrials.gov