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ACTIVE NOT RECRUITING

NCT01844986

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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

Official title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Key Details

Gender

FEMALE

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2013-08-26

Completion Date

2028-08-29

Last Updated

2025-12-10

Healthy Volunteers

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.

Inclusion Criteria: * Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal). * Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery. * 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 completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: * Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study. * Patients must be randomized within 8 weeks of their last dose of chemotherapy Exclusion Criteria: * BRCA1 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 with early stage disease (FIGO Stage I, IIA, IIB or IIC) * Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment. * Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible). * Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer. * Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease). * Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage \<2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Locations (177)

Clearview Cancer Institute

Huntsville, Alabama, United States

Providence Cancer Center

Anchorage, Alaska, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

Kaiser Permanente

Roseville, California, United States

Stanford Women's Cancer Center

Stanford, California, United States

Babak Edraki

Walnut Creek, California, United States

University of Colorado

Aurora, Colorado, United States

Univ of Connecticut Health Center

Farmington, Connecticut, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Gynecologic Cancer Center

Orlando, Florida, United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Nancy N. & J.C. Lewis Cancer and Research Pavillion

Savannah, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

University of Hawaii

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Univ Chicago Medical Center

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Vincent Hospital & Health Care Center

Indianapolis, Indiana, United States

Northern Indiana Cancer Research Consortium

Mishawaka, Indiana, United States

McFarland Clinic, P.C.

Ames, Iowa, United States

Norton Cancer Institute Research

Louisville, Kentucky, United States

Maine Medical Partners

Scarborough, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Gynecologic Oncology of West MI, PLLC

Grand Rapids, Michigan, United States

Minnesota Oncology Hematology, PA

Edina, Minnesota, United States

Mayo Clinic - Rochester, MN

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Valley Cancer Consortium CCOP

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Womens Cancer Center of Nevada

Las Vegas, Nevada, United States

MD Anderson at Cooper Cancer Center

Camden, New Jersey, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Women's Cancer Care Associates

Albany, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Mount Sinai Medical Center - New York

New York, New York, United States

Perlmutter Cancer Center

New York, New York, United States

Hope Women's Cancer Centers

Asheville, North Carolina, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Aultman Hospital

Canton, Ohio, United States

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University Hospital Case Medical Center

Cleveland, Ohio, United States

Research Site

Columbus, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Sanford Clinic Women's Health

Sioux Falls, South Dakota, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center of Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, United States

Aurora Baycare Medical Center

Green Bay, Wisconsin, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Froedtert Memorial Hospital

Milwaukee, Wisconsin, United States

Mercy Hospital for Women

Heidelberg, Australia

The Royal Womens Hospital

Parkville, Australia

Prince of Wales Hospital

Randwick, Australia

Centro Diagnóstico Barretos

Barretos, Brazil

Hospital Araujo Jorge

Goiânia, 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, Canada

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

CHUM - Hopital Norte-Dame

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

Beijing Cancer Hospital

Beijing, China

And 77 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (177)