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

NCT01874353 · tracked via the Priya Life Science USA tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2013-09-03

Last updated

2026-07-29

Condition(s) studied

Platinum SensitiveBRCA MutatedRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based Chemotherapy

Investigational drug(s) / intervention(s)

Olaparib 300mg tabletsPlacebo to match olaparib 300mg

Olaparib 300mg tablets: 300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Placebo to match olaparib 300mg: 300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

130 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) — 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.
To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.

Trial sites (126)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
Palo Alto Foundation Medical Group	San Francisco	California
University of Colorado	Aurora	Colorado
The Hospital of Central Connecticut	New Britain	Connecticut
Gynecologic Cancer Center	Orlando	Florida
North Shore University	Evanston	Illinois
Greater Baltimore Medical Center	Baltimore	Maryland
Johns Hopkins	Baltimore	Maryland
Dana Farber Cancer Institute	Boston	Massachusetts
Massachusetts General Hospital	Boston	Massachusetts
MD Anderson at Cooper Cancer Center	Voorhees Township	New Jersey
Womens Cancer Care Associates	Albany	New York
Winthrop Gynecologic Oncology Associates	Mineola	New York
OSU JamesCare at Mill Run	Hilliard	Ohio
Henry Joyce Cancer Clinic	Nashville	Tennessee
Aurora St Lukes Medical Center	Milwaukee	Wisconsin
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
Centro de Novos Tratamentos Itajai	Itajaí	Brazil
Hospital de Clinicas de Porto Alegre	Porto Alegre	Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre	Porto Alegre	Brazil
Hospital de Base São José do Rio Preto	São José do Rio Preto	Brazil
Centro de Referencia da Saude da Mulher	São Paulo	Brazil
Instituto do Câncer de São Paulo	São Paulo	Brazil
Juravinski Cancer Centre	Hamilton	Ontario
London Health Sciences Centre	London	Ontario
Princess Margaret Cancer Centre	Toronto	Ontario
Sunnybrook Health Sciences Center	Toronto	Ontario
CHUM - Hopital Norte-Dame	Montreal	Quebec
Hotel-Dieu de Quebec	Québec	Quebec
CHUS Site Fleurimont	Sherbrooke	Quebec
Beijing Cancer Hospital	Beijing	China
The Tumor Hospital affiliated to China Medical Science Insti	Beijing	China

+ 86 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01874353 on ClinicalTrials.gov ↗ ← All trials in the USA