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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy

In brief

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

Key facts

Study ID

NCT01874353

Run by

AstraZeneca

People needed

327

Starts

2013-09-03

Expected to finish

2026-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be ≥ 18 years of age.
• Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
• Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
• Patients who have received at least 2 previous lines of platinum containing therapy prior to randomisation
• For the penultimate chemotherapy course prior to enrolment on the study:
• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
• For the last chemotherapy course immediately prior to randomisation on the study:
• Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
• Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
• Patients must be randomized within 8 weeks of their last dose of chemotherapy
• Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab

You may not qualify if…

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc.)
• Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.

Where it is running

• Palo Alto Foundation Medical Group — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Gynecologic Cancer Center — Orlando, Florida, United States
• North Shore University — Evanston, Illinois, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• MD Anderson at Cooper Cancer Center — Voorhees Township, New Jersey, United States
• Womens Cancer Care Associates — Albany, New York, United States
• Winthrop Gynecologic Oncology Associates — Mineola, New York, United States
• OSU JamesCare at Mill Run — Hilliard, Ohio, United States
• Henry Joyce Cancer Clinic — Nashville, Tennessee, United States
• Aurora St Lukes Medical Center — Milwaukee, Wisconsin, United States
• Mercy Hospital for Women — Heidelberg, Australia
• The Royal Womens Hospital — Parkville, Australia
• Prince of Wales Hospital — Randwick, Australia
• U.Z. Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Centro Diagnóstico Barretos — Barretos, Brazil
• Centro Regional Integrado de Oncologia — Fortaleza, Brazil
• Hospital Araujo Jorge — Goiânia, Brazil
• Hospital de Caridade de Ijuí — Ijuí, Brazil
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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