Ovarian Cancer Clinical Trial

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

Summary

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

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT01844986

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 2 Locations for this study

See Locations Near You

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
Saint 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, 43210, 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
Itajai , , 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
Quebec , , Canada
Beijing Cancer Hospital
Beijing , , China
The Tumor Hospital affiliated to China Medical Science Insti
Beijing , , China
1st Hospital of Jilin university
Changchun , , China
Jilin Provincial Cancer Hospital
Changchun , , China
Hunan Cancer Hospital
Changsha , , China
West China Hospital Affiliated to Sichuan University
Chengdu , , China
ChongQing Cancer Hospital
Chongqing , , China
Research Site
Guangzhou , 51006, China
Women's Hospital, Zhejaing University School of Medicine
Hangzhou , , China
The Tumour Hospital of Harbin Medical University
Harbin , , China
Zhejiang Cancer Hospital, Huangzhou
Huangzhou , , China
JINAN, Qi Lu Hosp. of SD Univ.
Ji Nan , , China
Obstetris and Gynecology Hospital of Fudan University
Shanghai , , China
Shanghai Cancer Hospital of Fudan University
Shanghai , , China
The First Affiliated Hospital of Soochow Universit
Suzhou , , China
First affiliated hospital college of XianJiaotong University
Xian , , China
Institut Bergonie
Bordeaux , , France
CAC François Baclesse
Caen Cedex , , France
69LYON, C Bérard, Onco
Lyon Cedex 08 , , France
Centre Catherine de Sienne
Nantes, , , France
75PARIS, H Tenon, Onco
Paris , , France
Centre Alexis Vautrin
Vandoeuvre Les Nancy , , France
Institut Gustave Roussy
Villejuif Cedex , , France
Rambam Health Care Campus
Haifa , , Israel
Sapir Medical Centre
Kfar Saba , , Israel
Rabin MC
Petach Tikva , , Israel
Chaim Sheba Medical Centre
Tel Hashomer , , Israel
Tel-Aviv Sourkasy Medical Center
Tel-Aviv , , Israel
Bari- Istituto Tumori Giovanni Paolo II
Bari , , Italy
Azienda Ospedaliera "Cannizzaro"
Catania , , Italy
Istituto Europeo di Oncologia
Milano , , Italy
Istituto Nazionale Per Cura Tumori - Milano
Milano , , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli , , Italy
Istituto Oncologico Veneto Irccs
Padova , , Italy
Istituto Regina Elena-Polo Oncologico Ifo
Roma , , Italy
Policlinico Universitario A. Gemelli
Roma , , Italy
Hyogo CC
Akashi-shi , , Japan
National Cancer Center Hosp
Chuo-ku , , Japan
NHO Kyushu CC
Fukuoka , , Japan
Saitama Med. Univ. Int. Med. C
Hidaka-shi , , Japan
NHO Shikoku Cancer Center
Matsuyama-shi , , Japan
Niigata Univ. Med. Dent.
Niigata-shi , , Japan
Hokkaido University Hospital
Sapporo-shi , , Japan
Shizuoka Cancer Center
Sunto-gun , , Japan
National Cancer Center
Goyang-si , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Gangnam Severance Hospital
Seoul , , Korea, Republic of
Korea Cancer Center Hospital
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
Amsterdam , , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht , , Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
Grzepnica , , Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn , , Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn , , Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warszawa , , Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
Warszawa , , Poland
Udmurtia Republic Clinical Oncology Center
Izhevsk , , Russian Federation
Chemotherapy Department, Russian Cancer Research Centre
Moscow , , Russian Federation
State Institution of Heath Omsk Regional Oncology Dispensary
Omsk , , Russian Federation
Cancer Research Institute
Saint Petersburg , , Russian Federation
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg , , Russian Federation
Leningrad Regional Oncology Dispensary
St.Petersburg , , Russian Federation
Research Institute of Oncology RAMS
Tomsk , , Russian Federation
Barcelona,H.Vall d´Hebrón,Oncología
Barcelona , , Spain
Córdoba,H.Reina Sofía,Oncología
Córdoba , , Spain
H.Llobregat,ICO-Duran i Reynals,Oncología
Hospitalet deLlobregat(Barcelo , , Spain
Madrid, MD Anderson, Oncología
Madrid , , Spain
Madrid,H.U.La Paz,Oncología
Madrid , , Spain
Valencia, IVO, Oncología
Valencia , , Spain
Valencia,H.C.U.Valencia,Oncología
Valencia , , Spain
City Hospital, Birmingham, Cancer Trials Team
Birmingham , , United Kingdom
Addenbrooke's Hospital
Cambridge , , United Kingdom
Arden Cancer Centre
Coventry , , United Kingdom
Edinburgh Cancer Research UK Centre
Edinburgh , , United Kingdom
Cancer Research UK and UCL Cancer Trials Centre
London , , United Kingdom
Royal Marsden Hospital
London , , United Kingdom
Royal Marsden Hospital and Institute of Cancer Research
Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT01844986

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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