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 May 2015 by Clovis Oncology, Inc.
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01891344
First received: June 20, 2013
Last updated: May 7, 2015
Last verified: May 2015
  Purpose

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:
  • Disease Progression (RECIST v1.1) as assessed by investigator, or death from any cause, in molecularly-defined subgroups identified by a prospectively defined HRD signature (PART 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 ]
  • ORR by RECIST v1.1 (PART 2) [ 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:
  • ORR by RECIST v1.1 (PART 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 (RECIST v1.1). ] [ Designated as safety issue: No ]
  • Disease Progression (RECIST v1.1) as assessed by investigator, or death from any cause, in molecularly-defined subgroups identified by a prospectively defined HRD signature (PART 2) [ 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 ]
  • ORR by RECIST v1.1 and GCIG CA-125 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 ] [ Designated as safety issue: No ]
  • Duration of response per RECIST v1.1 [ 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 rucaparib concentrations [ Time Frame: 2 weeks, 1 month, 2 months and 3 months after 1st dose ] [ Designated as safety issue: No ]
  • Overall Survival (PART 2) [ Time Frame: study data collection expected to last for ~2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: September 2013
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ovarian cancer
rucaparib
Drug: Oral rucaparib
600 mg BID
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 to ARIEL2 PART 2 and 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.

This study will include 2 parts:

PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease

PART 2 (currently enrolling): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens

  Eligibility

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

The following eligibility criteria pertain to patients enrolling into PART 2 of the study:

Inclusion:

  • Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen
  • Relapsed/progressive disease as confirmed by CT scan
  • Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation
  • Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses

Exclusion:

  • 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
  • Hospitalization for bowel obstruction within 3 months prior to enrollment
  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 ClinicalTrials.gov identifier: NCT01891344

Contacts
Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Information +1-303-625-5160 (ex-USA) clovistrials@emergingmed.com

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Katherine Center       kcenter@uacc.arizona.edu   
United States, California
Saint Jude Heritage Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Gayle Madden-Mathes       gayle.madden-mathes@stjoe.org   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90404
Contact: Suzanne Branch       sbranch@mednet.ucla.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Calvin Cheung       cheungc@cc.ucsf.edu   
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Contact: Jessica Free       jfree@ohmacc.com   
Central Coast Medical Oncology Recruiting
Santa Maria, California, United States, 93454
Contact: Maria Meija       mariameija@mednet.ucla.edu   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Ashley Powell       ashleypowell@stanford.edu   
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Lakewood, Colorado, United States, 80228
Contact: Bobbie Donnachaidh       bobbie.donnachaidh@usoncology.com   
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kendra Brown       brown.kendra@mayo.edu   
United States, Indiana
Horizon BioAdvance Recruiting
Lafayette, Indiana, United States, 47905
Contact: Alison Long       along@horizonbioadvance.com   
United States, Maryland
Johns Hopkins Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Denise Wolfson       dwolfso3@jhmi.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kimberley MacNeill       kimberley_macneill@dfci.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Llazar Cuko       lcuko@mgh.harvard.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Burton       burton@mayo.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lynne Lippmann       lippmannl@wudosis.wustl.edu   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89014
Contact: Donna Katz       donnakatz@mednet.ucla.edu   
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kathy Bell-McGuinn       bell-mck@mskcc.org   
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Benson Joseph       benson.joseph@nyumc.org   
United States, North Carolina
Hope - A Woman's Cancer Institute Withdrawn
Asheville, North Carolina, United States, 28006
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Holly Steigelman       Holly.Steigelman@osumc.edu   
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73019
Contact: Carie Snowbarger       carie-snowbarger@ouhsc.edu   
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       Jessica.Marchesi@uphs.upenn.edu   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Taren Johnston       tjohnston@mdanderson.org   
United States, Washington
University of Washington - Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
Contact: Monica Dherin       mdherin@fhcrc.org   
Australia, New South Wales
Prince of Wales Hospital Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Christie Norris       christie.norris@sesiahs.health.nsw.gov.au   
Australia, Queensland
Royal Brisbane & Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Jenny Campbell       jenny_campbell@health.qld.gov.au   
Australia, South Australia
Flinders Cancer Clinic - Flinders Medical Centre (FMC) Recruiting
Bedfork Park, South Australia, Australia, 5042
Contact: Alison Richards       alison.richards@health.sa.gov.au   
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Marian Lieschke       marian.lieschke@mh.org.au   
Australia, Western Australia
Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Judy Innes-Rowe       judy.innes-rowe@health.wa.gov.au   
Australia
Crown Princess Mary Cancer Centre Recruiting
Westmead, Australia
Contact: Serene Leow       serene.leow@health.nsw.gov.au   
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N4N2
Contact: Pillay Leela       leela.pillay@albertahealthservices.ca   
Cross Cancer Centre Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Contact: Sarah Gracie       sara.gracie@albertahealthservices.ca   
Canada, British Columbia
Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA) Recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Contact: Kikine Capier       kcapier@bccancer.bc.ca   
Canada, Ontario
Juravinski Cancer Centre Withdrawn
Hamilton, Ontario, Canada, L8V5C2
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A4L6
Contact: Laura Bailey       laurad.bailey@lhsc.on.ca   
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Doreen Whelan       dwhelan@toh.on.ca   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Karen Chang       karen.chang@uhn.ca   
Canada, Quebec
Centre Hospitalier de L'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Nathalie Grenier       nathalie.grenier.chum@ssss.gouv.qc.ca   
France
Institut Bergonie Recruiting
Bordeaux, Aquitaine, France, 33076
Contact: Benedicte Benetreau       b.benetreau@bordeaux.unicancer.fr   
Hopital Hotel-Dieu Recruiting
Paris, Ile-de-France, France, 75181
Contact: Celine LeRest       celine.le-rest@egp.aphp.fr   
Hopital Tenon Recruiting
Paris, Ile-de-France, France, 75020
Contact: Stephane Provent       stephane.provent@tnn.aphp.fr   
Institut de cancerologie Gustave Roussy Recruiting
Villejuif, Ile-de-France, France, 94805
Contact: Melissa Vallee       melissa.vallee@gustaveroussy.fr   
Institut Claudius Regaud Recruiting
Toulouse, Midi-Pyrenees, France, 31052
Contact: Emmanuelle Carrie       carrie.emmanuelle@iuct-oncopole.fr   
Centre Catherine de Sienne Recruiting
Nantes, Pays de la Loire, France, 44202
Contact: Aurelie Fougeres       fougeres.aurelie@catherinedesienne.fr   
Centre Leon Berard Recruiting
Lyon, Rhone-Alpes, France, 69373
Contact: Pierre Metral       pierre.metral@lyon.unicancer.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre-Benite, Rhone-Alpes, France, 69495
Contact: Catherine Barrois       catherine.barrois01@chu-lyon.fr   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Contact: Olga Padros       opadros@vhebron.net   
Hospital Clinico Universitario de Valencia Withdrawn
Valencia, Spain, 46010
Instituto Valencia de Oncologia Recruiting
Valencia, Spain, 46009
Contact: Laura Calabuig       coordinacion@fincivo.org   
United Kingdom
Beatson West of Scotland Cancer Centre Active, not recruiting
Glasgow, Scotland, United Kingdom, G120YN
Royal Marsden Sutton Hospital Active, not recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
St James University Hospital Active, not recruiting
Leeds, West Yorkshire, United Kingdom, LS97TF
Addenbrooke's Hospital Active, not recruiting
Cambridge, United Kingdom, CB20QQ
Royal Marsden NHS Foundation Trust Active, not recruiting
Cambridge, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital Active, not recruiting
London, United Kingdom, W120HS
University College London Active, not recruiting
London, United Kingdom, W1T4TJ
The Christie NHS Foundation Trust Active, not recruiting
Manchester, United Kingdom, M204BX
Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care Active, not recruiting
Newcastle upon Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01891344     History of Changes
Other Study ID Numbers: CO-338-017
Study First Received: June 20, 2013
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Ministry of Health
Spain: Ministry of Health

Keywords provided by Clovis Oncology, Inc.:
rucaparib
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
CO-338
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
ARIEL2
ARIEL 2
ARIEL3
ARIEL 3

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on July 27, 2015