Research & Clinical Trials

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NCT01891344

A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

Note: This study is also known as the ARIEL2 StudyARIEL Logo

Study identifier: NCT01891344
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Rucaparib (Clovis)

Eligibility:

  • Confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer
  • Relapsed/progressive disease as confirmed by CT scan
  • Received ≥1 prior platinum-based treatment regimen
  • Received platinum-based regimen as last treatment
  • Sensitive to last platinum regimen (disease progression >6 months after the last dose of platinum)
  • If <55 years of age at diagnosis, prior history of breast cancer, or close relative (first or second degree) with ovarian cancer or early onset (<age 50) breast cancer, must have been previously tested for a BRCA mutation
  • Have biopsiable and measurable disease

Exclusion criteria:

  • History of prior cancer except for non-melanoma skin cancer, curatively treated solid tumor (>5 years ago without evidence of recurrence) or curatively treated breast cancer (>3 years ago without evidence of recurrence)
  • Prior treatment with any PARP inhibitor
  • Symptomatic and/or untreated central nervous system metastases
  • Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of rucaparib

Type of study:

Phase II

Treatment:

  • All patients will receive oral rucaparib twice a day continuously until disease progression.

Study sites in United States: Please note, the following sites will be opening the ARIEL2 study but are not yet open.

Contact study coordinators below where listed. For more information about ARIEL2 and all open sites visit the ARIEL study webpage, email: clinicaltrialinfo@clovisoncology.com or phone: 303-625-5185.

Arizona
Tucson
University of Arizona Cancer Center

California
Santa Monica
University of California Los Angeles

Colorado
Lakewood
Rocky Mountain Cancer Centers

Indiana
Lafayette
Horizon BioAdvance
Contact: Alison Long along@horizonbioadvance.com

Maryland
Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Massachusetts
Boston
Dana-Farber Cancer Institute

Minnesota
Rochester
Mayo Clinic

Missouri
St. Louis
Washington University School of Medicine

New York
New York City
Memorial Sloan-Kettering Cancer Center

New York University Langone Medical Center

Ohio
Columbus
The Ohio State University

Oklahoma
Oklahoma City
University of Oklahoma Medical Center

Pennsylvania
Philadelphia
Fox Chase Cancer Center

University of Pennsylvania

Texas
Houston
MD Anderson Cancer Center

Washington
Seattle
University of Washington at Seattle


International study sites

Australia
Bedford Park, SA
Flinders Medical Centre
Contact: Alison Richards, alison.richards@health.sa.gov.au

Herston, QLD
Royal Brisbane and Women's Hospital
Contact: Jenny Campbell

Parkville, VIC
Royal Melbourne Hospital
Contact: Marian Lieschke, marian.lieschke@mh.org.au

Randwick, NSW
Prince of Wales Hospital
Contact: Christie Norris, christie.norris@sesiahs.health.nsw.gov.au

West Perth, WA
Sir Charles Gairdner Hospital
Contact: Judy Innes-Rowe, Judy.Innes-Rowe@health.wa.gov.au

Westmead, NSW
Westmead Millennium Institute
Contact: Vicky Wegener, vicky.wegener@sydney.edu.au

Canada
Calgary, AB
Tom Baker Cancer Centre
Contact: Ms Leela Pillay, leela.pillay@albertahealthservices.ca

Toronto, ON
Princess Margaret Hospital
Contact: Chantale Blattler, chantale.blattler@uhn.ca

Vancouver, BC
British Columbia Cancer Agency, Vancouver Centre
Contact: Kikine Capier, kcapier@bccancer.bc.ca

United Kingdom
Glasgow, Scotland
Beatson Cancer Centre, Glasgow

London, England
Imperial College Healthcare NHS Trust

Royal Marsden NHS Trust

University College London

Newcastle Upon Tyne, England
Northern Centre for Cancer Care


Page updated 09/25/13