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Spots Global Cancer Trial Database for Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

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Trial Identification

Brief Title: Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

Official Title: A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )

Study ID: NCT01968213

Interventions

Rucaparib
Placebo

Study Description

Brief Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Detailed Description: Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also derived significant benefit. Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Arizona Cancer Center, Tucson, Arizona, United States

Saint Jude Heritage Medical Center, Fullerton, California, United States

UC Davis Comprehensive Cancer Center, Sacramento, California, United States

University of California San Francisco (UCSF), San Francisco, California, United States

Coastal Integrative Cancer Care, San Luis Obispo, California, United States

Central Coast Medical Oncology, Santa Maria, California, United States

University of California Los Angeles (UCLA), Santa Monica, California, United States

Rocky Mountain Cancer Centers, Lakewood, Colorado, United States

Memorial Healthcare System, Hollywood, Florida, United States

Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Florida Hospital, Orlando, Florida, United States

Johns Hopkins Universty, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Karmanos Cancer Institute - Wayne State University, Detroit, Michigan, United States

Washington University School of Medicine - Division of Gynaecological Oncology, Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Hope Women's Cancer Centers, Asheville, North Carolina, United States

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

University of Washington at Seattle, Seattle, Washington, United States

Prince of Wales Hospital, Sydney, New South Wales, Australia

Westmead Hospital, Westmead, New South Wales, Australia

Royal Brisbane & Women's Hospital, Herston, Queensland, Australia

Flinders Medical Centre, Bedford Park, South Australia, Australia

Royal Melbourne Hospital, Parkville, Victoria, Australia

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

St John of God Hospital Subiaco, Subiaco, Western Australia, Australia

AZ St Augustinus, Antwerpen, , Belgium

UZ Gent, Gent, , Belgium

UZ Leuven, Leuven, , Belgium

Clinique Sainte-Elisabeth, Namur, , Belgium

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

Juravinski Cancer Centre, Hamilton, Ontario, Canada

London Regional Cancer Centre, London, Ontario, Canada

Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

CHUM Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec, Quebec, , Canada

Centre Francois Baclesse, Caen Cedex 05, Basse-Normandie, France

Institut Gustave Roussy, Villejuif, Ile De France, France

Hôpital Européen Georges-Pompidou, Paris, Ile-de-France, France

Institut Claudius Regaud, Toulouse, Midi-Pyrenees, France

Centre Catherine de Sienne, Nantes Cedex, Pays De La Loire, France

Centre Leon Berard, Lyon, Rhone-Alpes, France

Centre Hospitalier Lyon Sud, Pierre Benite, Rhone-Alpes, France

Institute Bergonie, Bordeaux, , France

Hospital Tenon, Paris, , France

Klinikum Stuttgart, Stuttgart, Baden-Wuerttemberg, Germany

Klinikum Ludwigsburg-Bietigheim gGmbH, Ludwigsburg, Baden-Wuerttembert, Germany

Rotkreuzklinikum Muenchen gGmbH, Munich, Bavaria, Germany

Universitätsklinikum Frankfurt, Frankfurt am Main, Hessen, Germany

Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie, Wiesbaden, Hessen, Germany

Klinikum Chemnitz gGmbH, Chemnitz, Sachsen, Germany

Technische Universität Dresden, Dresden, Sachsen, Germany

Rambam Health Care Campus, Haifa, , Israel

Lady Davis Carmel Medical Center, Haifa, , Israel

Rabin Medical Center, Petach-Tikva, , Israel

Oncology Institute, Sheba Medical Center, Ramat Gan, , Israel

Sourasky Medical Center, Tel-Aviv, , Israel

Assaf Harofeh M.C., Zerifin, , Israel

Oncology Unit City Hospital degli Infermi, Faenza, Ravenna, Italy

Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, Reggio Nella Emilia, Italy

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy

Fondazione IRCCS National Cancer Institute, Milan, , Italy

Instituto Europeo di Oncologia, Milan, , Italy

Azienda Ospedaliero Universitaria Policlinico di Modena, Modena, , Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy

Policlinico Universitario Agostino Gemelli, Roma, , Italy

Auckland City Hospital, Auckland, Grafton, New Zealand

Palmsteron North Hospital, Palmerston North, Manawatu, New Zealand

Wellington Hospital, Newtown, Wellington, New Zealand

Hospital Central de Asturias, Oviedo, Asturias, Spain

Centro Oncologico de Galica, A Coruna, , Spain

Hospital Vall D'Hebron, Barcelona, , Spain

Hospital Ramón y Cajal, Madrid, , Spain

Hospital Universitario San Carlos, Madrid, , Spain

Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid, , Spain

Hospital Regional Universitario Carlos Haya de Malaga, Malaga, , Spain

Hospital Universitario Virgen del Rocío, Sevilla, , Spain

Instituto Valencia de Oncologia-Fundacion, Valencia, , Spain

Hospital Clinico Universitario de Valencia, Valencia, , Spain

Royal Marsden Hospital, London, England, United Kingdom

Belfast City Hospital, Belfast, Northern Ireland, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

St. James University Hospital, Leeds, West Yorkshire, United Kingdom

Addenbrookes Hospital, Cambridge, , United Kingdom

Barts Health NHS Trust, London, , United Kingdom

Imperial College Healthcare NHS Trust, London, , United Kingdom

Sarah Cannon Reserach Institute UK, London, , United Kingdom

University College London, London, , United Kingdom

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care, Newcastle Upon Tyne, , United Kingdom

Contact Details

Name: Heidi Giordano

Affiliation: Clovis Oncology, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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