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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Heidi Giordano
Affiliation: Clovis Oncology, Inc.
Role: STUDY_DIRECTOR