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
Conditions
Ovarian Cancer - Fallopian Tube Cancer - Peritoneal Cancer
Conditions: official terms
Fallopian Tube Neoplasms - Ovarian Neoplasms - Peritoneal Neoplasms
Conditions: Keywords
ARIEL3, ARIEL 3, platinum sensitive, PARP Inhibitor, rucaparib, homologous recombination, homologous recombination deficiency, CO-338, PF 01367338, AG 14699, platinum sensitive ovarian cancer, platinum sensitive fallopian tube cancer, platinum sensitive primary peritoneal cancer, platinum sensitive peritoneal cancer, gynecological cancer, Clovis, Clovis Oncology
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Rucaparib Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.

- Received ≥2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance therapy in this trial.

- Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen.

- Must have had at least a 6-month disease-free period following prior treatment with the penultimate platinum-based chemotherapy and achieved a response.

- For the last chemotherapy course prior to study entry, patients must have received a platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined by RECIST) and/or a GCIG CA-125 response.

- Have sufficient archival tumor tissue for analysis.

Exclusion Criteria:

- History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer.

- Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible.

- Untreated or symptomatic central nervous system metastases.

- Pre-existing duodental stent and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drug.

- Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study.
Locations
University of Arizona Cancer Center
Tucson, Arizona, United States
Status: Recruiting
Contact: Heather Wright - hwright@uacc.arizona.edu
Saint Jude Heritage Medical Center
Fullerton, California, United States
Status: Recruiting
Contact: Gayle Madden-Mathes - gayle.madden-mathes@stjoe.org
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Status: Withdrawn
University of California San Francisco (UCSF)
San Francisco, California, United States
Status: Recruiting
Contact: Paul Watkins - watkinsp@cc.ucsf.edu
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Status: Recruiting
Contact: Jessica Free - jfree@ohmacc.com
Central Coast Medical Oncology
Santa Maria, California, United States
Status: Recruiting
Contact: Maria Mejia - mariamejia@mednet.ucla.edu
University of California Los Angeles (UCLA)
Santa Monica, California, United States
Status: Recruiting
Contact: Suzanne Branch - sbranch@mednet.ucla.edu
Stanford University Hospital and Clinics
Stanford, California, United States
Status: Withdrawn
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Status: Recruiting
Contact: Mary Rigden - Mary.Rigden@usoncology.com
Memorial Healthcare System
Hollywood, Florida, United States
Status: Recruiting
Contact: Sharon Berbick - sberbick@mhs.net
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Andrew Nilson - a.nilson@med.miami.edu
Florida Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Jane Crofton - jane.crofton@flhosp.org
Johns Hopkins Universty
Baltimore, Maryland, United States
Status: Recruiting
Contact: Deborah Armstrong - jhcccro@jhmi.edu
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Allison Ambrosio - aambrosio@partners.org
Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, United States
Status: Recruiting
Contact: Marianne Garcia - garciam@karmanos.org
Washington University School of Medicine - Division of Gynaecological Oncology
St. Louis, Missouri, United States
Status: Recruiting
Contact: Lynne Lippmann - lippmannl@wudosis.wustl.edu
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Katherine Bell-McGuinn - bell-mck@mskcc.org
Hope Women's Cancer Centers
Asheville, North Carolina, United States
Status: Recruiting
Contact: Alisha Meade - ameade@hopewcc.com
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Holly Steigelman - Holly.Steigelman@osumc.edu
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Status: Withdrawn
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Klara Balint - kbalint@mail.med.upenn.edu
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Marcia Morris - mlmorris@mdanderson.org
University of Washington at Seattle
Seattle, Washington, United States
Status: Recruiting
Contact: Monica Dherin - mdherin@uw.edu
Prince of Wales Hospital
Sydney, New South Wales, Australia
Status: Recruiting
Contact: Sharon McKenzie - sharon.mckenzie@sesiahs.health.nsw.gov.au
Westmead Hospital
Westmead, New South Wales, Australia
Status: Recruiting
Contact: Serene Leow - serene.leow@health.nsw.gov.au
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Status: Recruiting
Contact: Annette Cubitt - annette.cubitt@health.qld.gov.au
Flinders Medical Centre
Bedford Park, South Australia, Australia
Status: Recruiting
Contact: Alison Richards - alison.richards@health.sa.gov.au
Royal Melbourne Hospital
Parkville, Victoria, Australia
Status: Recruiting
Contact: Linda Garrett - linda.garrett@mh.org.au
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Status: Recruiting
Contact: Judy Innes-Rowe - judy.innes-rowe@health.wa.gov.au
St John of God Hospital Subiaco
Subiaco, Western Australia, Australia
Status: Recruiting
Contact: Joanne Youd - joanne.youd@sjog.org.au
AZ St Augustinus
Antwerpen, Belgium
Status: Recruiting
Contact: Hilde Lavaerts - hilde.lavaerts@gza.be
UZ Gent
Gent, Belgium
Status: Recruiting
Contact: Stefanie Victor - stefanie.victor@uzgent.be
UZ Leuven
Leuven, Belgium
Status: Recruiting
Contact: Mieke Verrecas - mieke.verrecas@uzleuven.be
Clinique Sainte-Elisabeth
Namur, Belgium
Status: Recruiting
Contact: Dominique Crasson - dominique.crasson@cmsenamur.be
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Contact: Leela Pillay - leela.pillay@albertahealthservices.ca
Cross Cancer Institute
Edmonton, Alberta, Canada
Status: Recruiting
Contact: Sarah Gracie - sara.gracie@albertahealthservices.ca
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Lorraine Elit - laurie.elit@hrcc.on.ca
London Regional Cancer Centre
London, Ontario, Canada
Status: Recruiting
Contact: Laura Bailey - laurad.bailey@lhsc.on.ca
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Doreen Whelan - dwhelan@toh.on.ca
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Agnes Walters - agnes.walters@uhn.ca
CHUM Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Status: Recruiting
Contact: Nathalie Grenier - nathalie.grenier.chum@ssss.gouv.qc.ca
CHU de Québec L'Hôtel-Dieu de Québec
Quebec, Canada
Status: Recruiting
Contact: Geneviève Filion - genevieve.filion@crchuq.ulaval.ca
Centre Francois Baclesse
Caen Cedex 05, Basse-Normandie, France
Status: Recruiting
Contact: Astrid Letiembre - a.letiembre@mail.baclesse.fr
Institut Gustave Roussy
Villejuif, Ile De France, France
Status: Recruiting
Contact: Melissa Vallee - melissa.vallee@gustaveroussy.fr
Hopital Hotel-Dieu
Paris, Ile-de-France, France
Status: Recruiting
Contact: Celine LeRest - celine.le-rest@egp.aphp.fr
Institut Claudius Regaud
Toulouse, Midi-Pyrenees, France
Status: Recruiting
Contact: Emmanuelle Carrie - carrie.emmanuelle@iuct-oncopole.fr
Centre Catherine de Sienne
Nantes Cedex, Pays De La Loire, France
Status: Recruiting
Contact: Aurelie Fougeres - fougeres.aurelie@catherinedesienne.fr
Centre Leon Berard
Lyon, Rhone-Alpes, France
Status: Recruiting
Contact: Pierre Metral - pierre.metral@lyon.unicancer.fr
Centre Hospitalier Lyon Sud
Pierre Benite, Rhone-Alpes, France
Status: Recruiting
Contact: Diane Augu - ext-diane.augu@chu-lyon.fr
Institute Bergonie
Bordeaux, France
Status: Recruiting
Contact: Benedicte Benetreau - b.benetreau@bordeaux.unicancer.fr
Hospital Tenon
Paris, France
Status: Recruiting
Contact: Stéphane Provent - stephane.provent@tnn.aphp.fr
Klinikum Stuttgart
Stuttgart, Baden-Wuerttemberg, Germany
Status: Withdrawn
Klinikum Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Baden-Wuerttembert, Germany
Status: Recruiting
Contact: Tania Carmone - tania.carmone@kliniken-lb.de
Rotkreuzklinikum Muenchen gGmbH
Munich, Bavaria, Germany
Status: Recruiting
Contact: Reisch Harry - harry.reisch@swmbrk.de
Universitätsklinikum Frankfurt
Frankfurt am Main, Hessen, Germany
Status: Recruiting
Contact: Stefan M Loitsch - stefanmarcel.loitsch@kgu.de
Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie
Wiesbaden, Hessen, Germany
Status: Recruiting
Contact: Heike Busse - heike.busse@hsk-wiesbaden.de
Klinikum Chemnitz gGmbH
Chemnitz, Sachsen, Germany
Status: Recruiting
Contact: Katja Thierfelder - k.thierfelder@skc.de
Technische Universität Dresden
Dresden, Sachsen, Germany
Status: Recruiting
Contact: Christine Griebsch - christine.griebsch@uniklinikum-dresden.de
Lady Davis Carmel Medical Center
Haifa, Israel
Status: Recruiting
Contact: Mali Azencot - maliaz@clalit.org.il
Rambam Health Care Campus
Haifa, Israel
Status: Recruiting
Contact: Geula Klorin - g_klorin@rambam.health.gov.il
Rabin Medical Center
Petach-Tikva, Israel
Status: Recruiting
Contact: Tamar Segal - tamar.segal@gmail.com
Oncology Institute, Sheba Medical Center
Ramat Gan, Israel
Status: Recruiting
Contact: Hilla Ben-Ami - hilla.benami@sheba.health.gov.il
Sourrasky Medical Center
Tel-Aviv, Israel
Status: Recruiting
Contact: Gali Hagler-Price - galihp@tlvmc.gov.il
Assaf Harofeh M.C.
Zerifin, Israel
Status: Recruiting
Contact: Sharona Ben-Ami - sharonab@asaf.health.gov.il
Hospital Central de Asturias
Oviedo, Asturias, Italy
Status: Recruiting
Contact: Esther Uriol Egido - uriolesther@telecable.es
Oncology Unit City Hospital degli Infermi
Faenza, Ravenna, Italy
Status: Recruiting
Contact: Alessandra Piancastelli - fa.datamanager@ausl.ra.it
Arcispedale Santa Maria Nuova IRCCS
Reggio Emilia, Reggio Nella Emilia, Italy
Status: Recruiting
Contact: Roberta Gnoni - gnoni.roberta@asmn.re.it
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy
Status: Recruiting
Contact: Cinzia Pizzirani - cinzia.pizzirani@aosp.bo.it
Fondazione IRCCS National Cancer Institute
Milan, Italy
Status: Recruiting
Contact: Balbina Apice - balbinaapice@hotmail.it
Instituto Europeo di Oncologia
Milan, Italy
Status: Recruiting
Contact: Sara Boveri - sara.boveri@ieo.it
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
Status: Recruiting
Contact: Pasquale Mighali - pasquale.mighali@unimore.it
Policlinico Universitario Agostino Gemelli
Roma, Italy
Status: Recruiting
Contact: Isabella Goglia - ginecol1@rm.unicatt.it
Auckland City Hospital
Auckland, Grafton, New Zealand
Status: Recruiting
Contact: Beth Caudwell - bcaudwell@adhb.govt.nz
Palmsteron North Hospital
Palmerston North, Manawatu, New Zealand
Status: Recruiting
Contact: Tania Simpson - tania.simpson@midcentraldhb.govt.nz
Wellington Hospital
Newtown, Wellington, New Zealand
Status: Recruiting
Contact: Jayne Bowers - jayne.bowers@ccdhb.org.nz
Centro Oncologico de Galica
A Coruna, Spain
Status: Recruiting
Contact: Begona Uriarte - uriarte.b@gmail.com
Hospital Vall D'Hebron
Barcelona, Spain
Status: Recruiting
Contact: Olga Padros - opadros@vhebron.net
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, Spain
Status: Recruiting
Contact: Miriam Delgado - mdelgado@fundacionhm.com
Hospital Ramón y Cajal
Madrid, Spain
Status: Recruiting
Contact: Luis Barba - luis.barba@salud.madrid.org
Hospital Universitario San Carlos
Madrid, Spain
Status: Recruiting
Contact: Jesús M Domínguez - mariajesusdoni@gmail.com
Hospital Materno-Infantil
Malaga, Spain
Status: Recruiting
Contact: Irene Rojas - ensayosch@yahoo.es
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Status: Withdrawn
Hospital Clinico Universitario de Valencia
Valencia, Spain
Status: Withdrawn
Instituto Valencia de Oncologia-Fundacion
Valencia, Spain
Status: Recruiting
Contact: Pedro Mallol - datamanager1@fincivo.org
Royal Marsden Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Lesley Murphy - lesley.murphy@rmh.nhs.uk
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Status: Recruiting
Contact: Debbie Rai - debbie.rai@glasgow.ac.uk
St. James University Hospital
Leeds, West Yorkshire, United Kingdom
Status: Recruiting
Contact: Charlotte Pool - charlotte.pool@leedsth.nhs.uk
Addenbrookes Hospital
Cambridge, United Kingdom
Status: Recruiting
Contact: Chloe Bryan - chloe.bryan@addenbrookes.nhs.uk
Barts Health NHS Trust
London, United Kingdom
Status: Recruiting
Contact: Katie Hall - katie.hall@christie.nhs.uk
Imperial College Healthcare NHS Trust
London, United Kingdom
Status: Recruiting
Contact: Emily Pickford - emily.pickford@imperial.nhs.uk
Sarah Cannon Reserach Institute UK
London, United Kingdom
Status: Withdrawn
University College London
London, United Kingdom
Status: Recruiting
Contact: Lola Osinnowo - ololade.osinnowo@uclh.nhs.uk
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Recruiting
Contact: Katie Hall - katie.hall@christie.nhs.uk
Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care
Newcastle Upon Tyne, United Kingdom
Status: Recruiting
Contact: Jared Thornton - jared.thornton@newcastle.ac.uk
Start Date
January 2014
Completion Date
November 2016
Sponsors
Clovis Oncology, Inc.
Source
Clovis Oncology, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page