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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Clovis Oncology, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc. Identifier:
First received: June 20, 2013
Last updated: December 12, 2014
Last verified: December 2014

The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.

Condition Intervention Phase
Ovarian Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: Oral rucaparib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

Resource links provided by NLM:

Further study details as provided by Clovis Oncology, Inc.:

Primary Outcome Measures:
  • Progression-free survival per RECIST version 1.1 [ Time Frame: Screening; at the end of every 8 weeks (±4 days) of treatment; at disease progression; study data collection expected to last for ~2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response rate achieved (from baseline to disease progression) per RECIST version 1.1 and GCIG CA-125 response criteria. [ Time Frame: Screening; at the end of every 8 weeks (±4 days) of treatment; at disease progression; study data collection expected to last for ~2 years (RECIST v1.1). ] [ Designated as safety issue: No ]
    Screening, Day 1 of every cycle, at the end of every 8 weeks (±4 days) of treatment, as clinically indicated, and at disease progression (GCIG CA-125 response criteria).

  • Duration of response per RECIST version 1.1 [ Time Frame: Screening; at the end of every 8 weeks (±4 days) of treatment; at disease progression; study data collection expected to last for ~2 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events, clinical laboratory abnormalities, and dose modifications [ Time Frame: Every day starting with signing of consent until 28 days after discontinuation of treatment; study data collection expected to last for ~2 years ] [ Designated as safety issue: Yes ]
  • Trough (Cmin) level of rucaparib concentrations [ Time Frame: 2 weeks, 1 month, 2 months and 3 months after 1st dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ovarian cancer
All patients with platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer will take oral rucaparib
Drug: Oral rucaparib
All patients will ingest rucaparib twice a day continuously until disease progression. Patients may take rucaparib on an empty stomach or with food. Each dose should be taken with at least 8 oz (240 mL) of room temperature water. Tablets should be swallowed whole. Each patient will take the Recommended Phase 2 Dose established in the CO-338-010 study.
Other Names:
  • CO-338
  • PF 01367338
  • AG 14699

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). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.

Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms.

Once determined, this signature will be prospectively applied in the final analysis of the planned Phase 3 pivotal study (ARIEL3). This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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; continuous or switch maintenance treatment as part of this regimen is permitted
  • 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 gBRCA mutation; after 15 patients harboring the gBRCA mutation are enrolled, no additional patients with a known gBRCA mutation will be allowed to enroll.
  • Have biopsiable and measurable disease

Exclusion Criteria:

  • History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
  • Prior treatment with any PARP inhibitor
  • Symptomatic and/or untreated central nervous system metastases
  • Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01891344

Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA)
Contact: Clovis Oncology Clinical Trial Information +1-303-625-5160 (ex-USA)

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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Katherine Center   
United States, California
Saint Jude Heritage Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Gayle Madden-Mathes   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90404
Contact: Suzanne Branch   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Cara Pennacchio   
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Contact: Jessica Free   
Central Coast Medical Oncology Recruiting
Santa Maria, California, United States, 93454
Contact: Maria Meija   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Ashley Powell   
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Lakewood, Colorado, United States, 80228
Contact: Bobbie Donnachaidh   
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kendra Brown   
United States, Indiana
Horizon BioAdvance Recruiting
Lafayette, Indiana, United States, 47905
Contact: Alison Long   
United States, Maryland
Johns Hopkins Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Denise Wolfson   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Llazar Cuko   
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kimberley MacNeill   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Burton   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lynne Lippmann   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89014
Contact: Donna Katz   
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kathy McGuinn   
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Benson Joseph   
United States, North Carolina
Hope - A Woman's Cancer Institute Recruiting
Asheville, North Carolina, United States, 28006
Contact: Alisha Meade   
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Holly Steigelman   
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73019
Contact: Carie Snowbarger   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Intake Number    888-309-2427      
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica Marchesi   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Taren Johnston   
United States, Washington
University of Washington - Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
Contact: Monica Dherin   
Australia, New South Wales
Prince of Wales Hospital Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Christie Norris   
Australia, Queensland
Royal Brisbane & Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Jenny Campbell   
Australia, South Australia
Flinders Cancer Clinic - Flinders Medical Centre (FMC) Recruiting
Bedfork Park, South Australia, Australia, 5042
Contact: Alison Richards   
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Marian Lieschke   
Australia, Western Australia
Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Judy Innes-Rowe   
Crown Princess Mary Cancer Centre Recruiting
Westmead, Australia
Contact: Serene Leow   
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N4N2
Contact: Pillay Leela   
Cross Cancer Centre Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Contact: Sarah Gracie   
Canada, British Columbia
Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA) Recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Contact: Kikine Capier   
Canada, Ontario
Juravinski Cancer Centre Withdrawn
Hamilton, Ontario, Canada, L8V5C2
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A4L6
Contact: Laura Bailey   
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Doreen Whelan   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Karen Chang   
Canada, Quebec
Centre Hospitalier de L'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Nathalie Grenier   
Institut Bergonie Recruiting
Bordeaux, Aquitaine, France, 33076
Contact: Benedicte Benetreau   
Hopital Hotel-Dieu Recruiting
Paris, Ile-de-France, France, 75181
Contact: Celine LeRest   
Hopital Tenon Recruiting
Paris, Ile-de-France, France, 75020
Contact: Stephane Provent   
Institut de cancerologie Gustave Roussy Recruiting
Villejuif, Ile-de-France, France, 94805
Contact: Melissa Vallee   
Institut Claudius Regaud Recruiting
Toulouse, Midi-Pyrenees, France, 31052
Contact: Emmanuelle Carrie   
Centre Catherine de Sienne Recruiting
Nantes, Pays de la Loire, France, 44202
Contact: Aurelie Fougeres   
Centre Leon Berard Recruiting
Lyon, Rhone-Alpes, France, 69373
Contact: Pierre Metral   
Centre Hospitalier Lyon Sud Recruiting
Pierre-Benite, Rhone-Alpes, France, 69495
Contact: Catherine Barrois   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Contact: Olga Padros   
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Inmaculada Blasco   
Instituto Valencia de Oncologia Recruiting
Valencia, Spain, 46009
Contact: Laura Calabuig   
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G120YN
Contact: Debbie Rai   
Royal Marsden Sutton Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Michele Everard   
St James University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS97TF
Contact: Charlotte Pool   
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB20QQ
Contact: Shelley Hugill   
Royal Marsden NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Contact: Lesley Murphy   
Imperial College Healthcare NHS Trust - Hammersmith Hospital Recruiting
London, United Kingdom, W120HS
Contact: Emily Pickford   
University College London Recruiting
London, United Kingdom, W1T4TJ
Contact: Egla Aitkens   
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M204BX
Contact: Linzi Davies   
Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care Recruiting
Newcastle upon Tyne, United Kingdom, NE77DN
Contact: Jared Thornton   
Sponsors and Collaborators
Clovis Oncology, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Clovis Oncology, Inc. Identifier: NCT01891344     History of Changes
Other Study ID Numbers: CO-338-017
Study First Received: June 20, 2013
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: National Health Service
France: Ministry of Health
Spain: Ministry of Health

Keywords provided by Clovis Oncology, Inc.:
PF 01367338
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
peritoneal cancer
platinum sensitive
relapsed disease
PARP Inhibitor
homologous recombination
homologous recombination deficiency
genomic scarring
loss of heterozygosity
AG 14699
platinum sensitive ovarian cancer
platinum sensitive fallopian tube cancer
platinum sensitive primary peritoneal cancer
platinum sensitive peritoneal cancer
gynecological cancer
Clovis Oncology

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms processed this record on March 26, 2015