Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) (ARIEL3)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring 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
Eligibility 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 duodenal 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.
Sites / Locations
- University of Arizona Cancer Center
- Saint Jude Heritage Medical Center
- UC Davis Comprehensive Cancer Center
- University of California San Francisco (UCSF)
- Coastal Integrative Cancer Care
- Central Coast Medical Oncology
- University of California Los Angeles (UCLA)
- Rocky Mountain Cancer Centers
- Memorial Healthcare System
- Sylvester Comprehensive Cancer Center
- Florida Hospital
- Johns Hopkins Universty
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Karmanos Cancer Institute - Wayne State University
- Washington University School of Medicine - Division of Gynaecological Oncology
- Memorial Sloan-Kettering Cancer Center
- Hope Women's Cancer Centers
- The Ohio State University Wexner Medical Center
- University of Pennsylvania
- University of Texas MD Anderson Cancer Center
- University of Washington at Seattle
- Prince of Wales Hospital
- Westmead Hospital
- Royal Brisbane & Women's Hospital
- Flinders Medical Centre
- Royal Melbourne Hospital
- Sir Charles Gairdner Hospital
- St John of God Hospital Subiaco
- AZ St Augustinus
- UZ Gent
- UZ Leuven
- Clinique Sainte-Elisabeth
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Juravinski Cancer Centre
- London Regional Cancer Centre
- Ottawa Hospital Cancer Centre
- Princess Margaret Cancer Centre
- CHUM Centre Hospitalier de l'Université de Montréal
- Centre Hospitalier Universitaire de Québec
- Centre Francois Baclesse
- Institut Gustave Roussy
- Hôpital Européen Georges-Pompidou
- Institut Claudius Regaud
- Centre Catherine de Sienne
- Centre Leon Berard
- Centre Hospitalier Lyon Sud
- Institute Bergonie
- Hospital Tenon
- Klinikum Stuttgart
- Klinikum Ludwigsburg-Bietigheim gGmbH
- Rotkreuzklinikum Muenchen gGmbH
- Universitätsklinikum Frankfurt
- Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie
- Klinikum Chemnitz gGmbH
- Technische Universität Dresden
- Rambam Health Care Campus
- Lady Davis Carmel Medical Center
- Rabin Medical Center
- Oncology Institute, Sheba Medical Center
- Sourasky Medical Center
- Assaf Harofeh M.C.
- Oncology Unit City Hospital degli Infermi
- Arcispedale Santa Maria Nuova IRCCS
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Fondazione IRCCS National Cancer Institute
- Instituto Europeo di Oncologia
- Azienda Ospedaliero Universitaria Policlinico di Modena
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
- Policlinico Universitario Agostino Gemelli
- Auckland City Hospital
- Palmsteron North Hospital
- Wellington Hospital
- Hospital Central de Asturias
- Centro Oncologico de Galica
- Hospital Vall D'Hebron
- Hospital Ramón y Cajal
- Hospital Universitario San Carlos
- Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
- Hospital Regional Universitario Carlos Haya de Malaga
- Hospital Universitario Virgen del Rocío
- Instituto Valencia de Oncologia-Fundacion
- Hospital Clinico Universitario de Valencia
- Royal Marsden Hospital
- Belfast City Hospital
- Beatson West of Scotland Cancer Centre
- The Royal Marsden NHS Foundation Trust
- St. James University Hospital
- Addenbrookes Hospital
- Barts Health NHS Trust
- Imperial College Healthcare NHS Trust
- Sarah Cannon Reserach Institute UK
- University College London
- The Christie NHS Foundation Trust
- Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rucaparib
Placebo
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.