Trial record 10 of 18 for:    parp inhibitor ovarian | Open Studies

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.
Verified April 2014 by Clovis Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01891344
First received: June 20, 2013
Last updated: April 9, 2014
Last verified: April 2014
  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:
  • Best overall response rate achieved (from baseline to disease progression) per RECIST version 1.1 and GCIG CA-125 response criteria. [ Time Frame: Screening; within 7 days of every odd numbered cycle, i.e. prior to the start of Cycle 3, 5, 7, etc; at disease progression; study data collection expected to last for ~2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response per RECIST version 1.1 [ Time Frame: Screening; within 7 days of every odd numbered cycle, i.e. prior to the start of Cycle 3, 5, 7, etc; at disease progression; study data collection expected to last for ~2 years ] [ Designated as safety issue: No ]
  • Progression-free survival per RECIST version 1.1 [ Time Frame: Screening; within 7 days of every odd numbered cycle, i.e. prior to the start of Cycle 3, 5, 7, etc; 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 (with a regular meal or within 30 minutes after a regular meal). 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 genetic alterations in a patient's tumor and observed clinical benefit from rucaparib treatment. It is anticipated that BRCA and other genes known to be involved in HR will be part of such a signature.

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.

  Eligibility

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

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891344

Contacts
Contact: Clovis Oncology Clinical Trial Information clinicaltrialinfo@clovisoncology.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 Not yet recruiting
San Francisco, California, United States, 94115
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, 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
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Llazar Cuko       lcuko@mgh.harvard.edu   
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kimberley MacNeill       kimberley_macneill@dfci.harvard.edu   
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Not yet 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 McGuinn       bell-mck@mskcc.org   
New York University Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
United States, North Carolina
Hope - A Woman's Cancer Institute Not yet recruiting
Asheville, North Carolina, United States, 28006
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kori Fenner       kori.fenner@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 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
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 Not yet recruiting
Seattle, Washington, United States, 98195
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 Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Australia
Crown Princess Mary Cancer Centre Recruiting
Westmead, Australia
Contact: Serene Leow       serene.leow@health.nsw.gov.au   
Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada, T2N4N2
Cross Cancer Centre Not yet recruiting
Edmonton, Alberta, Canada, T6G1Z2
Canada, British Columbia
Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA) Not yet recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Canada, Ontario
Juravinski Cancer Centre Not yet recruiting
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: Agnes Walters       agnes.walters@uhn.ca   
France
Institut Bergonie Recruiting
Bordeaux, Aquitaine, France, 33076
Contact: Benedicte Benetreau       b.benetreau@bordeaux.unicancer.fr   
Centre Francois Baclesse Not yet recruiting
Caen, Basse-Normandie, France, 14076
Hopital Tenon Not yet recruiting
Paris, Ile-de-France, France, 75020
Hopital Hotel-Dieu Not yet recruiting
Paris, Ile-de-France, France, 75181
Institut de cancerologie Gustave Roussy Not yet recruiting
Villejuif, Ile-de-France, France, 94805
Institut Claudius Regaud Not yet recruiting
Toulouse, Midi-Pyrenees, France, 31052
Centre Catherine de Sienne Not yet recruiting
Nantes, Pays de la Loire, France, 44202
Centre Leon Berard Not yet recruiting
Lyon, Rhone-Alpes, France, 69373
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre-Benite, Rhone-Alpes, France, 69495
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Contact: Olga Padros       opadros@vhebron.net   
Instituto Valencia de Oncologia Not yet recruiting
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain, 46010
United Kingdom
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, Scotland, United Kingdom, G120YN
St James University Hospital Not yet recruiting
Leeds, West Yorkshire, United Kingdom, LS97TF
Royal Marsden NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB20QQ
University College London Not yet recruiting
London, United Kingdom, W1T4TJ
Imperial College Healthcare NHS Trust - Hammersmith Hospital Not yet recruiting
London, United Kingdom, W120HS
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M204BX
Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Clovis Oncology, Inc.
  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: April 9, 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

Keywords provided by Clovis Oncology, Inc.:
ovarian cancer
PARP Inhibitor
platinum sensitive ovarian cancer
fallopian tube cancer
primary peritoneal cancer
peritoneal cancer
platinum sensitive
relapsed disease
rucaparib
homologous recombination
homologous recombination deficiency
CO-338
PF 01367338
AG 14699
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:
Ovarian Neoplasms
Ovarian Diseases
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 23, 2014