Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

564

Study ID:

NCT01968213

Recruitment Status:

Active, not recruiting

Sponsor:

Clovis Oncology, Inc.

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There are 95 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85704, United States
Saint Jude Heritage Medical Center
Fullerton California, 92835, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
University of California San Francisco (UCSF)
San Francisco California, 94158, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93422, United States
Central Coast Medical Oncology
Santa Maria California, 93454, United States
University of California Los Angeles (UCLA)
Santa Monica California, 90404, United States
Rocky Mountain Cancer Centers
Lakewood Colorado, 80228, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Florida Hospital
Orlando Florida, 32804, United States
Johns Hopkins Universty
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute - Wayne State University
Detroit Michigan, 48201, United States
Washington University School of Medicine - Division of Gynaecological Oncology
Saint Louis Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Hope Women's Cancer Centers
Asheville North Carolina, 28806, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Washington at Seattle
Seattle Washington, 98109, United States
Prince of Wales Hospital
Sydney New South Wales, 2031, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital
Herston Queensland, 4029, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Royal Melbourne Hospital
Parkville Victoria, 3052, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
St John of God Hospital Subiaco
Subiaco Western Australia, 608, Australia
AZ St Augustinus
Antwerpen , 2610, Belgium
UZ Gent
Gent , B-900, Belgium
UZ Leuven
Leuven , 3000, Belgium
Clinique Sainte-Elisabeth
Namur , 5000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N4N, Canada
Cross Cancer Institute
Edmonton Alberta, T6G1Z, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada
London Regional Cancer Centre
London Ontario, N6A4L, Canada
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H8L, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G2M, Canada
CHUM Centre Hospitalier de l'Université de Montréal
Montreal Quebec, H2L4M, Canada
Centre Hospitalier Universitaire de Québec
Quebec , G1R2J, Canada
Centre Francois Baclesse
Caen Cedex 05 Basse-Normandie, 14076, France
Institut Gustave Roussy
Villejuif Ile De France, 94805, France
Hôpital Européen Georges-Pompidou
Paris Ile-de-France, 75908, France
Institut Claudius Regaud
Toulouse Midi-Pyrenees, 31052, France
Centre Catherine de Sienne
Nantes Cedex Pays De La Loire, 44202, France
Centre Leon Berard
Lyon Rhone-Alpes, 69373, France
Centre Hospitalier Lyon Sud
Pierre Benite Rhone-Alpes, 69495, France
Institute Bergonie
Bordeaux , 33076, France
Hospital Tenon
Paris , 75020, France
Klinikum Stuttgart
Stuttgart Baden-Wuerttemberg, 70174, Germany
Klinikum Ludwigsburg-Bietigheim gGmbH
Ludwigsburg Baden-Wuerttembert, 71640, Germany
Rotkreuzklinikum Muenchen gGmbH
Munich Bavaria, 80637, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main Hessen, 60596, Germany
Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie
Wiesbaden Hessen, 65199, Germany
Klinikum Chemnitz gGmbH
Chemnitz Sachsen, 09116, Germany
Technische Universität Dresden
Dresden Sachsen, 01307, Germany
Rambam Health Care Campus
Haifa , 31096, Israel
Lady Davis Carmel Medical Center
Haifa , , Israel
Rabin Medical Center
Petach-Tikva , 49100, Israel
Oncology Institute, Sheba Medical Center
Ramat Gan , 52621, Israel
Sourasky Medical Center
Tel-Aviv , 64239, Israel
Assaf Harofeh M.C.
Zerifin , 70300, Israel
Oncology Unit City Hospital degli Infermi
Faenza Ravenna, 48018, Italy
Arcispedale Santa Maria Nuova IRCCS
Reggio Emilia Reggio Nella Emilia, 42100, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Fondazione IRCCS National Cancer Institute
Milan , 20133, Italy
Instituto Europeo di Oncologia
Milan , 20141, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena , 41124, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli , 80131, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00158, Italy
Auckland City Hospital
Auckland Grafton, 1023, New Zealand
Palmsteron North Hospital
Palmerston North Manawatu, 4442, New Zealand
Wellington Hospital
Newtown Wellington, 6021, New Zealand
Hospital Central de Asturias
Oviedo Asturias, 33011, Spain
Centro Oncologico de Galica
A Coruna , 15009, Spain
Hospital Vall D'Hebron
Barcelona , 8035, Spain
Hospital Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario San Carlos
Madrid , 28040, Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid , 28050, Spain
Hospital Regional Universitario Carlos Haya de Malaga
Malaga , 29011, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Instituto Valencia de Oncologia-Fundacion
Valencia , 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Royal Marsden Hospital
London England, SW3 6, United Kingdom
Belfast City Hospital
Belfast Northern Ireland, BT9 7, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow Scotland, G120Y, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
St. James University Hospital
Leeds West Yorkshire, LS97T, United Kingdom
Addenbrookes Hospital
Cambridge , CB20Q, United Kingdom
Barts Health NHS Trust
London , EC1M6, United Kingdom
Imperial College Healthcare NHS Trust
London , W120H, United Kingdom
Sarah Cannon Reserach Institute UK
London , W1G6A, United Kingdom
University College London
London , W1T4T, United Kingdom
The Christie NHS Foundation Trust
Manchester , M204B, United Kingdom
Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care
Newcastle Upon Tyne , NE77D, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

564

Study ID:

NCT01968213

Recruitment Status:

Active, not recruiting

Sponsor:


Clovis Oncology, Inc.

How clear is this clinincal trial information?

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