Phase
Condition
Recurrent Ovarian Cancer
Allergy (Pediatric)
Allergy
Treatment
Placebo to match olaparib 300mg
Olaparib 300mg tablets
Clinical Study ID
Ages 18-130 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must be ≥ 18 years of age.
Female patients with histologically diagnosed relapsed high grade serousovarian cancer (including primary peritoneal and / or fallopian tube cancer) orhigh grade endometrioid cancer.
Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious orsuspected deleterious (known or predicted to be detrimental/lead to loss offunction).
Patients who have received at least 2 previous lines of platinum containingtherapy 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 orcomplete radiological response), or may have no evidence of disease (if optimalcytoreductive surgery was conducted prior to chemotherapy), and no evidence of arising CA-125, following completion of this chemotherapy course
Patient must have received a platinum based chemotherapy regimen (e.g. carboplatinor 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
Exclusion Criteria:
Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff 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 theirlast chemotherapy regimen prior to enrolment on the study.
Study Design
Study Description
Connect with a study center
Mercy Hospital for Women
Heidelberg,
AustraliaSite Not Available
The Royal Womens Hospital
Parkville,
AustraliaSite Not Available
Prince of Wales Hospital
Randwick,
AustraliaSite Not Available
Research Site
Brussels (Woluw?-St-Lambert),
BelgiumSite Not Available
Research Site
Brussels (Woluwé-St-Lambert),
BelgiumSite Not Available
UCL Saint-Luc
Brussels (Wuluw-St-Lambert),
BelgiumSite Not Available
U.Z. Gent
Gent,
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven,
BelgiumSite Not Available
Hospital Araujo Jorge
Goiania, GO
BrazilSite Not Available
Hospital de Caridade de Ijuí
Ijui, RS
BrazilSite Not Available
Hospital da Cidade de Passo Fundo
Passo Fundo, Rio Grande Do Sul
BrazilSite Not Available
Centro de Referencia da Saude da Mulher
Sao Paulo, SP
BrazilSite Not Available
Fundacao da Faculdade Regional de Sao Jose do Rio Preto
Sao Jose Do Rio Preto, Sao Paulo
BrazilSite Not Available
Centro Diagnóstico Barretos
Barretos,
BrazilSite Not Available
Centro Regional Integrado de Oncologia
Fortaleza,
BrazilSite Not Available
Hospital Araujo Jorge
Goiânia,
BrazilSite Not Available
Hospital de Caridade de Ijuí
Ijuí,
BrazilSite Not Available
Centro de Novos Tratamentos Itajai
Itajai,
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre,
BrazilSite Not Available
Irmandade da Santa Casa de Misericordia de Porto Alagre
Porto Alegre,
BrazilSite Not Available
Instituto Nacional do Cancer
Rio de Janeiro,
BrazilSite Not Available
Hospital de Base São José do Rio Preto
São José do Rio Preto,
BrazilSite Not Available
Centro de Referencia da Saude da Mulher
São Paulo,
BrazilSite Not Available
Instituto do Câncer de São Paulo
São Paulo,
BrazilSite Not Available
Juravinski Cancer Centre
Hamilton, Ontario
CanadaSite Not Available
London Health Sciences Centre
London, Ontario
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario
CanadaSite Not Available
Sunnybrook Health Sciences Center
Toronto, Ontario
CanadaSite Not Available
CHUM - Hopital Norte-Dame
Montreal, Quebec
CanadaSite Not Available
CHUS Site Fleurimont
Sherbrooke, Quebec
CanadaSite Not Available
Hotel-Dieu de Quebec
Quebec,
CanadaSite Not Available
Beijing Cancer Hospital
Beijing,
ChinaSite Not Available
The Tumor Hospital affiliated to China Medical Science Insti
Beijing,
ChinaSite Not Available
1st Hospital of Jilin university
Changchun,
ChinaSite Not Available
Jilin Provincial Cancer Hospital
Changchun,
ChinaSite Not Available
Hunan Cancer Hospital
Changsha,
ChinaSite Not Available
West China Hospital Affiliated to Sichuan University
Chengdu,
ChinaSite Not Available
ChongQing Cancer Hospital
Chongqing,
ChinaSite Not Available
Fujian general hospital of Nanjing Military Command
Fuzhou,
ChinaSite Not Available
Research Site
Guangzhou, 510060
ChinaSite Not Available
Women's Hospital, Zhejaing University School of Medicine
Hangzhou,
ChinaSite Not Available
The Tumour Hospital of Harbin Medical University
Harbin,
ChinaSite Not Available
Zhejiang Cancer Hospital, Huangzhou
Huangzhou,
ChinaSite Not Available
JINAN, Qi Lu Hosp. of SD Univ.
Ji Nan,
ChinaSite Not Available
JiangSu Cancer Hospital
Nanjing,
ChinaSite Not Available
Affiliated tumor hospital to Guangxi medical university
Nanning,
ChinaSite Not Available
Research Site
Shanghai, 200011
ChinaSite Not Available
Shanghai Cancer Hospital of Fudan University
Shanghai,
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou,
ChinaSite Not Available
First affiliated hospital college of XianJiaotong University
Xian,
ChinaSite Not Available
Institut Bergonie
Bordeaux,
FranceSite Not Available
CAC François Baclesse
Caen Cedex,
FranceSite Not Available
69LYON, C Bérard, Onco
Lyon Cedex 08,
FranceSite Not Available
Centre Catherine de Sienne
Nantes,
FranceSite Not Available
Centre Catherine de Sienne
Nantes,,
FranceSite Not Available
75PARIS, H Tenon, Onco
Paris,
FranceSite Not Available
Hopital Européen Georges Pompidou
Paris,
FranceSite Not Available
Institut Curie Paris Et Saint Cloud
Paris Cedex 5,
FranceSite Not Available
69PIERREBE, CH Lyon Sud,
Pierre Benite Cedex,
FranceSite Not Available
92STCLOUD, C Huguenin, Onco
Saint Cloud,
FranceSite Not Available
Institut Claudius Regaud
Toulouse,
FranceSite Not Available
Centre Alexis Vautrin
Vandoeuvre Les Nancy,
FranceSite Not Available
Institut Gustave Roussy
Villejuif Cedex,
FranceSite Not Available
Helios-Kliniken Berlin - Buch
Berlin,
GermanySite Not Available
Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen,
GermanySite Not Available
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
Essen,
GermanySite Not Available
Johann-Wolfgang Goethe-Universität
Frankfurt,
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover,
GermanySite Not Available
Klinikum der Universität zu Köln
Koln,
GermanySite Not Available
Klinikum der Universität zu Köln
Köln,
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein
Lubeck,
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein
Lübeck,
GermanySite Not Available
Research Site
Marburg,
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität
Munchen,
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität
München,
GermanySite Not Available
Onkologie Ravensburg
Ravensburg,
GermanySite Not Available
Universitätsklinikum Rostock
Rostock,
GermanySite Not Available
Rambam Health Care Campus
Haifa,
IsraelSite Not Available
Sapir Medical Centre
Kfar Saba,
IsraelSite Not Available
Tel Hashomer
Ramat Gan,
IsraelSite Not Available
Research Site
Tel Hashomer,
IsraelSite Not Available
Research Site
Genova, GE
ItalySite Not Available
Istituto Europeo di Oncologia
Milano,
ItalySite Not Available
Azienda Ospedaliera Policlinico Di Modena
Modena,
ItalySite Not Available
Istituto Nazionale Tumori Fondazione Pascale
Napoli,
ItalySite Not Available
Istituto Oncologico Veneto Irccs
Padova,
ItalySite Not Available
Istituto Regina Elena-Polo Oncologico Ifo
Roma,
ItalySite Not Available
Policlinico Universitario A. Gemelli
Roma,
ItalySite Not Available
Hyogo Cancer Center
Akashi-shi,
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku,
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center
Fukuoka,
JapanSite Not Available
Saitama Medical University International Medical Center
Hidaka-shi,
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi,
JapanSite Not Available
Niigata University Medical and Dental Hospital
Niigata-shi,
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi,
JapanSite Not Available
Hokkaido University Hospital
Sapporo-shi,
JapanSite Not Available
Shizuoka Cancer Center
Sunto-gun,
JapanSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
Amsterdam,
NetherlandsSite Not Available
Maastricht Universitair Medisch Centrum
Maastricht,
NetherlandsSite Not Available
Universitair Medisch Centrum St. Radboud
Nijmegen,
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam,
NetherlandsSite Not Available
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
Grzepnica,
PolandSite Not Available
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn,
PolandSite Not Available
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn,
PolandSite Not Available
Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
Warszawa,
PolandSite Not Available
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
Warszawa,
PolandSite Not Available
Chemotherapy Department, Russian Cancer Research Centre
Moscow,
Russian FederationSite Not Available
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg,
Russian FederationSite Not Available
Leningrad Regional Oncology Dispensary
St.Petersburg,
Russian FederationSite Not Available
Córdoba,H.Reina Sofía,Oncología
Cordoba, Andalucia
SpainSite Not Available
Barcelona,H.Clinic i Provincial,Oncología
Barcelona,
SpainSite Not Available
Barcelona,H.de la Sta.Creu i S.Pau,Oncología
Barcelona,
SpainSite Not Available
Córdoba,H.Reina Sofía,Oncología
Córdoba,
SpainSite Not Available
Gerona,H.Josep Trueta,Oncología
Gerona,
SpainSite Not Available
Madrid, H.C.S.Carlos,Oncología
Madrid,
SpainSite Not Available
Madrid,H.12 de Octubre,Oncología
Madrid,
SpainSite Not Available
Oviedo,H.Cent.Asturias,Onco
Oviedo,
SpainSite Not Available
Hospital Provincial de Navarra
Pamplona,
SpainSite Not Available
Valencia, IVO, Oncología
Valencia,
SpainSite Not Available
Valencia,H.C.U.Valencia,Oncología
Valencia,
SpainSite Not Available
City Hospital Birmingham Cancer Trials Team
Birmingham,
United KingdomSite Not Available
Addenbrooke's Hospital
Cambridge,
United KingdomSite Not Available
Arden Cancer Centre
Coventry,
United KingdomSite Not Available
Edinburgh Cancer Research UK Centre
Edinburgh,
United KingdomSite Not Available
Cancer Research UK and UCL Cancer Trials Centre
London,
United KingdomSite Not Available
Royal Marsden Hospital
London,
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester,
United KingdomSite Not Available
Royal Marsden Hospital and Institute of Cancer Research
Sutton,
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California
United StatesSite Not Available
Palo Alto Foundation Medical Group
San Francisco, California
United StatesSite Not Available
Palo Alto Foundation Medical Group
San Fransisco, California
United StatesSite Not Available
Research Site
Stanford, California
United StatesSite Not Available
University of Colorado
Aurora, Colorado
United StatesSite Not Available
The Hospital of Central Connecticut
New Britain, Connecticut
United StatesSite Not Available
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut
United StatesSite Not Available
Salom and Tangir LLC
Miramar, Florida
United StatesSite Not Available
Gynecologic Cancer Center
Orlando, Florida
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois
United StatesSite Not Available
North Shore University
Evanston, Illinois
United StatesSite Not Available
Greater Baltimore Medical Center
Baltimore, Maryland
United StatesSite Not Available
Johns Hopkins
Baltimore, Maryland
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts
United StatesSite Not Available
MD Anderson at Cooper Cancer Center
Camden, New Jersey
United StatesSite Not Available
MD Anderson at Cooper Cancer Center
Voorhees, New Jersey
United StatesSite Not Available
Womens Cancer Care Associates
Albany, New York
United StatesSite Not Available
Winthrop Gynecologic Oncology Associates
Mineola, New York
United StatesSite Not Available
Perlmutter Cancer Center
New York, New York
United StatesSite Not Available
OSU JamesCare at Mill Run
Hillard, Ohio
United StatesSite Not Available
OSU JamesCare at Mill Run
Hilliard, Ohio
United StatesSite Not Available
Research Site
Abington, Pennsylvania
United StatesSite Not Available
Henry Joyce Cancer Clinic
Nashville, Tennessee
United StatesSite Not Available
University of Texas
Houston, Texas
United StatesSite Not Available
Aurora St Lukes Medical Center
Milwaukee, Wisconsin
United StatesSite Not Available
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