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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:September 2016
End Date:June 2024
Contact:Clovis Oncology Clinical Trial Information
Email:clovistrials@emergingmed.com
Phone:1-855-262-3040 (USA)

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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

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.

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.

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
We found this trial at
14
sites
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Thomas Herzog, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Joseph Lucci, MD
Phone: 713-500-6382
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Augusta, Georgia 30912
Principal Investigator: Sharad Ghamande, MD
Phone: 706-721-8978
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Augusta, GA
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Denver, Colorado 80218
Principal Investigator: Ling Ma, MD
Phone: 303-385-2000
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Denver, CO
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Detroit, Michigan
Principal Investigator: Ira Winer, MD
Phone: 313-576-8994
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Detroit, MI
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Fortaleza,
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101 The City Drive South
Long Beach, California 92868
Principal Investigator: Krishnansu Tewari, MD
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Long Beach, CA
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Mineola, New York
Principal Investigator: Eva Chalas, MD
Phone: 516-294-1206
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Mineola, NY
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Monterey, California 93940
Principal Investigator: Laura Stampleman, MD
Phone: 831-375-4105
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Monterey, CA
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Orlando, Florida 32804
Principal Investigator: Robert Holloway, MD
Phone: 407-303-2090 ext: 1104286
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San Francisco, California 94143
Principal Investigator: Lee-May Chen, M.D.
Phone: 415-353-7957
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Scarborough, Maine 04074
Principal Investigator: Christopher Darus, MD
Phone: 207-883-7972
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Tucson, Arizona 85724
Principal Investigator: Janiel Cragun, MD
Phone: 520-694-9081
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