ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
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ClinicalTrials.gov Identifier: NCT02855944 |
Recruitment Status :
Recruiting
First Posted : August 4, 2016
Last Update Posted : July 2, 2019
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer | Drug: Chemotherapy Drug: Rucaparib | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 345 participants |
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 |
Study Start Date : | September 2016 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
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Experimental: Rucaparib
Drug: Oral rucaparib 600 mg BID Other Names: •CO-338
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Drug: Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice daily
Other Names:
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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:
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- 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 ]
- 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

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, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be 18 years of age at the time the informed consent form is signed
- 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 ≥ 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

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
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 |

United States, Arizona | |
The University of Arizona Cancer Center | Withdrawn |
Tucson, Arizona, United States, 85724 | |
United States, California | |
University of California Irvine Health Chao Family Comprehensive Cancer Center | Withdrawn |
Long Beach, California, United States, 92868 | |
Pacific Cancer Care | Withdrawn |
Monterey, California, United States, 93940 | |
University of California San Francisco | Withdrawn |
San Francisco, California, United States, 94158 | |
United States, Colorado | |
Rocky Mountain Cancer Center | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Heather Harsh 303-385-2000 heather.harsh@usoncology.com | |
Contact: Katherine Schleich 303-385-2000 katherine.schleich@usoncology.com | |
Principal Investigator: Ling Ma, MD | |
United States, Florida | |
Florida Hospital Cancer Institute | Withdrawn |
Orlando, Florida, United States, 32804 | |
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 | Withdrawn |
Scarborough, Maine, United States, 04074 | |
United States, Michigan | |
Karmanos Cancer Institute/Wayne State University | Withdrawn |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Women's Contemporary Care Associates (WCCA) - Mineola | Withdrawn |
Mineola, New York, United States | |
United States, Ohio | |
University of Cincinnati | Withdrawn |
Cincinnati, Ohio, United States | |
United States, Texas | |
The University of Texas Health Science Center at Houston | Withdrawn |
Houston, Texas, United States | |
United States, Washington | |
Seattle Cancer Care Alliance | Withdrawn |
Seattle, Washington, United States, 98109 | |
Brazil | |
Recruiting | |
Fortaleza, Ceara, Brazil | |
Recruiting | |
Curitiba, Parana, Brazil | |
Recruiting | |
Ijui, RIO Grande DO SUL, Brazil | |
Recruiting | |
Porto Alegre, RIO Grande DO SUL, Brazil | |
Recruiting | |
Florianópolis, Santa Catarina, Brazil | |
Recruiting | |
Barretos, SAO Paulo, Brazil | |
Recruiting | |
Rio de Janeiro, Brazil | |
Recruiting | |
Sao Paulo, Brazil | |
Canada, Alberta | |
Recruiting | |
Calgary, Alberta, Canada | |
Canada, Ontario | |
Withdrawn | |
London, Ontario, Canada | |
Recruiting | |
Ottawa, Ontario, Canada | |
Recruiting | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Recruiting | |
Montreal, Quebec, Canada | |
Recruiting | |
Montréal, Quebec, Canada | |
Recruiting | |
Sherbrooke, Quebec, Canada | |
Czechia | |
Recruiting | |
Brno, Jihormoravsky KRAJ, Czechia | |
Recruiting | |
Praha 5, Praha, Czechia | |
Recruiting | |
Ostrava, Czechia | |
Recruiting | |
Praha, Czechia | |
Hungary | |
Withdrawn | |
Miskolc, Borsod-abauj-zemplen, Hungary | |
Debreceni Egyetem Klinikai Központ | Recruiting |
Debrecen, Hajdu-bihar, Hungary | |
Országos Onkológiai Intézet | Recruiting |
Budapest, Hungary | |
Israel | |
Recruiting | |
Haifa, Israel | |
Recruiting | |
Holon, Israel | |
Recruiting | |
Jerusalem, Israel | |
Recruiting | |
Petach-Tikva, Israel | |
Recruiting | |
Tel Aviv, Israel | |
Recruiting | |
Tel Hashomer, Israel | |
Italy | |
Recruiting | |
Bologna, Italy | |
Recruiting | |
Candiolo, Italy | |
Recruiting | |
Catania, Italy | |
Recruiting | |
Milano, Italy | |
Recruiting | |
Modena, Italy | |
Recruiting | |
Napoli, Italy | |
Recruiting | |
Roma, Italy | |
Poland | |
Recruiting | |
Grzepnica, West Pomeranian Voivodeship, Poland | |
Recruiting | |
Bialystok, Poland | |
Withdrawn | |
Gdansk, Poland | |
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Recruiting |
Lublin, Poland | |
Recruiting | |
Olsztyn, Poland | |
Recruiting | |
Poznan, Poland | |
Recruiting | |
Szczecin, Poland | |
Russian Federation | |
Recruiting | |
Arkhangelsk, Russian Federation | |
Recruiting | |
Kursk, Russian Federation | |
Recruiting | |
Moscow, Russian Federation | |
Withdrawn | |
Nizhny Novgorod, Russian Federation | |
Recruiting | |
Omsk, Russian Federation | |
Recruiting | |
Pyatigorsk, Russian Federation | |
Recruiting | |
Ryazan, Russian Federation | |
Recruiting | |
Saint Petersburg, Russian Federation | |
Recruiting | |
Saint-Petersburg, Russian Federation | |
Recruiting | |
Saransk, Russian Federation | |
Recruiting | |
Sochi, Russian Federation | |
Recruiting | |
Ufa, Russian Federation | |
Spain | |
Recruiting | |
Barcelona, Spain | |
Recruiting | |
Girona, Spain | |
Recruiting | |
La Coruna, Spain | |
Recruiting | |
Madrid, Spain | |
Ukraine | |
Recruiting | |
Dnipropetrovsk, 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 | |
Velindre NHS Trust | Recruiting |
Cardiff, United Kingdom | |
Recruiting | |
Coventry, United Kingdom | |
Recruiting | |
Derby, United Kingdom | |
Recruiting | |
Dundee, United Kingdom | |
Recruiting | |
Glasgow, United Kingdom | |
Recruiting | |
London, United Kingdom | |
Recruiting | |
Middlesex, United Kingdom | |
Recruiting | |
Newcastle upon Tyne, United Kingdom |
Responsible Party: | Clovis Oncology, Inc. |
ClinicalTrials.gov Identifier: | NCT02855944 History of Changes |
Other Study ID Numbers: |
CO-338-043 |
First Posted: | August 4, 2016 Key Record Dates |
Last Update Posted: | July 2, 2019 |
Last Verified: | April 2019 |
ARIEL4 ARIEL-4 ARIEL 4 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 |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Rucaparib Antineoplastic Agents, Phytogenic Antineoplastic Agents |