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ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

This study is currently recruiting participants.
Verified June 2017 by Clovis Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02855944
First Posted: August 4, 2016
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
  Purpose
The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.

Condition Intervention Phase
Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Chemotherapy Drug: Rucaparib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Investigator assessed progression-free survival (invPFS) by RECIST Version 1.1 for rucaparib versus chemotherapy [ Time Frame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for the duration of the study, ~4 years ]

Secondary Outcome Measures:
  • Efficacy of rucaparib versus chemotherapy as measured by overall survival (OS) [ Time Frame: study data collection expected to last for ~5 years ]
  • Safety and tolerability of rucaparib versus chemotherapy assessed by AEs reported; clinical laboratory investigations; Vital signs; 12 lead ECGs; Physical examinations; and ECOG performance status [ Time Frame: study data collection expected to last for ~4 years ]
    This is a composite outcome. It will be assessed by Incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology and serum chemistry); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status


Estimated Enrollment: 345
Study Start Date: September 2016
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rucaparib

Drug: Oral rucaparib

600 mg BID Other Names: •CO-338

  • PF 01367338
  • AG 14699
  • Rubraca
Drug: Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice daily
Other Names:
  • CO-338
  • AG 14699
  • PF 01367338
  • Rubraca
Active Comparator: Chemotherapy

Monotherapy platinum (cisplatin or carboplatin) or platinum-based doublet chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.

Single agent paclitaxel will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.

Drug: Chemotherapy
Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Other Names:
  • Cisplatin
  • carboplatin
  • carboplatin/paclitaxel
  • carboplatin/gemcitabine
  • paclitaxel

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.

While PARP inhibitors have demonstrated consistent robust clinical activity in patients with relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and safety of PARPi versus standard of care chemotherapy have been limited. The primary purpose of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in their tumor.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years of age at the time the informed consent form is signed
  • Have a histologically confirmed Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
  • Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
  • Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses

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
  • Women who are pregnant or breast feeding
  • Hospitalization for bowel obstruction within 3 months prior to enrollment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855944


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
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States
Contact: Yrma Burruel    520-694-9081    yburruel@uacc.arizona.edu   
Contact: Jennie Collins    1 (520) 694-9067    jenniecollins@email.arizona.edu   
Principal Investigator: Janiel Cragun, MD         
United States, California
University of California Irvine Health Chao Family Comprehensive Cancer Center Recruiting
Long Beach, California, United States
Contact: Anita Wallick       awallick@uci.edu   
Principal Investigator: Krishnansu Tewari, MD         
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
Contact: Leslie Hohenbrink    831-375-4105    Lhohenbrink@pacificcancercare.com   
Principal Investigator: Laura Stampleman, MD         
Not yet recruiting
San Francisco, California, United States
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
Contact: Valerie Apodaca    303-285-5081    valerie.apodaca@usoncology.com   
Principal Investigator: Ling Ma, MD         
United States, Florida
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Jane LeBlanc    407-303-2090 ext: 1104286    jane.leblanc@flhosp.org   
Principal Investigator: Robert Holloway, MD         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Donna Wheatley    706-721-8978    dwheatley@augusta.edu   
Principal Investigator: Sharad Ghamande, MD         
United States, Maine
Maine Medical Center/Maine Medical Partners Women's Health Recruiting
Scarborough, Maine, United States, 04074
Contact: Robin Donovan    207-883-7972    donovr1@mmc.org   
Principal Investigator: Christopher Darus, MD         
United States, Michigan
Karmanos Cancer Institute/Wayne State University Recruiting
Detroit, Michigan, United States
Contact: Allison Wolgast    313-576-8994    wolgasta@karmanos.org   
Principal Investigator: Robert Morris, MD         
United States, New York
Women's Contemporary Care Associates (WCCA) - Mineola Recruiting
Mineola, New York, United States
Contact: Jennifer Brown    516-294-1206    jlbrown@winthrop.org   
Principal Investigator: Eva Chalas, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States
Contact: Lisa Woeste       lisa.woeste@uc.edu   
Principal Investigator: Thomas Herzog, MD         
United States, Texas
Not yet recruiting
Houston, Texas, United States
United States, Washington
Not yet recruiting
Seattle, Washington, United States
Brazil
Not yet recruiting
Salvador, Bahia, Brazil
Not yet recruiting
Fortaleza, Ceara, Brazil
Recruiting
Curitiba, Parana, Brazil
Recruiting
Ijui, Rio Grande Do Sul, Brazil
Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Not yet recruiting
Barretos, Sao Paulo, Brazil
Not yet recruiting
Rio de Janeiro, Brazil
Not yet recruiting
Sao Paulo, Brazil
Canada, Alberta
Not yet recruiting
Calgary, Alberta, Canada
Canada, Ontario
Not yet recruiting
London, Ontario, Canada
Not yet recruiting
Ottawa, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada
Recruiting
Sherbrooke, Quebec, Canada
Czechia
Recruiting
Brno, Jihormoravsky Kraj, Czechia
Recruiting
Praha 5, Praha, Czechia
Recruiting
Ostrava, Czechia
Recruiting
Praha, Czechia
Hungary
Not yet recruiting
Miskolc, Borsod-abauj-zemplen, Hungary
Debreceni Egyetem Klinikai Központ Recruiting
Debrecen, Hajdu-bihar, Hungary
Israel
Recruiting
Haifa, Israel
Not yet recruiting
Holon, Israel
Recruiting
Jerusalem, Israel
Recruiting
Petach-Tikva, Israel
Recruiting
Tel Aviv, Israel
Not yet recruiting
Tel Hashomer, Israel
Italy
Not yet recruiting
Bologna, Italy
Not yet recruiting
Candiolo, Italy
Recruiting
Catania, Italy
Recruiting
Milano, Italy
Recruiting
Modena, Italy
Recruiting
Napoli, Italy
Recruiting
Roma, Italy
Poland
Recruiting
Bialystok, Poland
Recruiting
Gdansk, Poland
Not yet recruiting
Grzepnica, Poland
Recruiting
Olsztyn, Poland
Recruiting
Poznan, Poland
Recruiting
Szczecin, Poland
Russian Federation
Not yet recruiting
Arkhangelsk, Russian Federation
Not yet recruiting
Kursk, Russian Federation
Not yet recruiting
Moscow, Russian Federation
Not yet recruiting
Nizhny Novgorod, Russian Federation
Not yet recruiting
Omsk, Russian Federation
Not yet recruiting
Pyatigorsk, Russian Federation
Not yet recruiting
Ryazan, Russian Federation
Not yet recruiting
Saint Petersburg, Russian Federation
Not yet recruiting
Saint-Petersburg, Russian Federation
Not yet recruiting
Saransk, Russian Federation
Not yet recruiting
Sochi, Russian Federation
Not yet recruiting
Ufa, Russian Federation
Spain
Recruiting
Barcelona, Spain
Recruiting
Girona, Spain
Recruiting
La Coruna, Spain
Recruiting
Madrid, Spain
Ukraine
Recruiting
Dnipropetrovsk, Ukraine
Not yet recruiting
Donets'k, Ukraine
Not yet recruiting
Kyiv, Ukraine
Recruiting
Kyiv, Ukraine
Recruiting
Lutsk, Ukraine
Recruiting
Lviv, Ukraine
Recruiting
Odessa, Ukraine
Recruiting
Sumy, Ukraine
Recruiting
Uzhgorod, Ukraine
United Kingdom
Recruiting
Manchester, England, United Kingdom
Recruiting
Sutton, Surrey, United Kingdom
Recruiting
Cambridge, United Kingdom
Not yet recruiting
Coventry, United Kingdom
Not yet recruiting
Derby, United Kingdom
Recruiting
Dundee, United Kingdom
Recruiting
Glasgow, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Middlesex, United Kingdom
Not yet recruiting
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
  More Information

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02855944     History of Changes
Other Study ID Numbers: CO-338-043
First Submitted: July 22, 2016
First Posted: August 4, 2016
Last Update Posted: June 16, 2017
Last Verified: June 2017

Keywords provided by Clovis Oncology, Inc.:
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
peritoneal cancer
platinum sensitive
relapsed disease
PARP Inhibitor
PARP
rucaparib
ruca
homologous recombination
homologous recombination deficiency
genomic scarring
loss of heterozygosity
CO-338
PF-01367338
PF 01367338
CO-338-043
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
ARIEL-2
ARIEL-3
ARIEL 3

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Paclitaxel
Gemcitabine
Rucaparib
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents