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

PHASE3CompletedINTERVENTIONAL
Enrollment

564

Participants

Timeline

Start Date

April 7, 2014

Primary Completion Date

April 1, 2017

Study Completion Date

July 7, 2022

Conditions
Ovarian CancerFallopian Tube CancerPeritoneal Cancer
Interventions
DRUG

Rucaparib

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.

DRUG

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.

Trial Locations (96)

608

St John of God Hospital Subiaco, Subiaco

1023

Auckland City Hospital, Auckland

2031

Prince of Wales Hospital, Sydney

2145

Westmead Hospital, Westmead

2610

AZ St Augustinus, Antwerp

3000

UZ Leuven, Leuven

3052

Royal Melbourne Hospital, Parkville

4029

Royal Brisbane & Women's Hospital, Herston

4442

Palmsteron North Hospital, Palmerston North

5000

Clinique Sainte-Elisabeth, Namur

5042

Flinders Medical Centre, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands

6021

Wellington Hospital, Newtown

8035

Hospital Vall D'Hebron, Barcelona

10065

Memorial Sloan-Kettering Cancer Center, New York

14076

Centre Francois Baclesse, Caen

15009

Centro Oncologico de Galica, A Coruña

19104

University of Pennsylvania, Philadelphia

20133

Fondazione IRCCS National Cancer Institute, Milan

20141

Instituto Europeo di Oncologia, Milan

21287

Johns Hopkins Universty, Baltimore

28034

Hospital Ramón y Cajal, Madrid

28040

Hospital Universitario San Carlos, Madrid

28050

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

28806

Hope Women's Cancer Centers, Asheville

29011

Hospital Regional Universitario Carlos Haya de Malaga, Málaga

31052

Institut Claudius Regaud, Toulouse

31096

Rambam Health Care Campus, Haifa

32804

Florida Hospital, Orlando

33011

Hospital Central de Asturias, Oviedo

33021

Memorial Healthcare System, Hollywood

33076

Institute Bergonie, Bordeaux

33136

Sylvester Comprehensive Cancer Center, Miami

40138

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

41013

Hospital Universitario Virgen del Rocío, Seville

41124

Azienda Ospedaliero Universitaria Policlinico di Modena, Modena

42100

Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia

43210

The Ohio State University Wexner Medical Center, Columbus

44202

Centre Catherine de Sienne, Nantes

46009

Instituto Valencia de Oncologia-Fundacion, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

48018

Oncology Unit City Hospital degli Infermi, Faenza

48201

Karmanos Cancer Institute - Wayne State University, Detroit

49100

Rabin Medical Center, Petah Tikva

52621

Oncology Institute, Sheba Medical Center, Ramat Gan

60596

Universitätsklinikum Frankfurt, Frankfurt am Main

63110

Washington University School of Medicine - Division of Gynaecological Oncology, St Louis

64239

Sourasky Medical Center, Tel Aviv

65199

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

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70174

Klinikum Stuttgart, Stuttgart

70300

Assaf Harofeh M.C., Ẕerifin

71640

Klinikum Ludwigsburg-Bietigheim gGmbH, Ludwigsburg

75020

Hospital Tenon, Paris

75908

Hôpital Européen Georges-Pompidou, Paris

77030

University of Texas MD Anderson Cancer Center, Houston

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

80228

Rocky Mountain Cancer Centers, Lakewood

80637

Rotkreuzklinikum Muenchen gGmbH, Munich

85704

University of Arizona Cancer Center, Tucson

90404

University of California Los Angeles (UCLA), Santa Monica

92835

Saint Jude Heritage Medical Center, Fullerton

93422

Coastal Integrative Cancer Care, San Luis Obispo

93454

Central Coast Medical Oncology, Santa Maria

94158

University of California San Francisco (UCSF), San Francisco

94805

Institut Gustave Roussy, Villejuif

95817

UC Davis Comprehensive Cancer Center, Sacramento

98109

University of Washington at Seattle, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

B-9000

UZ Gent, Ghent

T2N4N2

Tom Baker Cancer Centre, Calgary

T6G1Z2

Cross Cancer Institute, Edmonton

L8V5C2

Juravinski Cancer Centre, Hamilton

N6A4L6

London Regional Cancer Centre, London

K1H8L6

Ottawa Hospital Cancer Centre, Ottawa

M5G2M9

Princess Margaret Cancer Centre, Toronto

H2L4M1

CHUM Centre Hospitalier de l'Université de Montréal, Montreal

G1R2J6

Centre Hospitalier Universitaire de Québec, Québec

09116

Klinikum Chemnitz gGmbH, Chemnitz

01307

Technische Universität Dresden, Dresden

Unknown

Lady Davis Carmel Medical Center, Haifa

00158

Policlinico Universitario Agostino Gemelli, Roma

SW3 6JJ

Royal Marsden Hospital, London

BT9 7AB

Belfast City Hospital, Belfast

G120YN

Beatson West of Scotland Cancer Centre, Glasgow

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

LS97TF

St. James University Hospital, Leeds

CB20QQ

Addenbrookes Hospital, Cambridge

EC1M6BQ

Barts Health NHS Trust, London

W120HS

Imperial College Healthcare NHS Trust, London

W1G6AD

Sarah Cannon Reserach Institute UK, London

W1T4TJ

University College London, London

M204BX

The Christie NHS Foundation Trust, Manchester

NE77DN

Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care, Newcastle upon Tyne

All Listed Sponsors
collaborator

Foundation Medicine

INDUSTRY

collaborator

Myriad Genetics, Inc.

INDUSTRY

lead

pharmaand GmbH

INDUSTRY