Last updated on April 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02855944

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Augusta University

Augusta, GA United States
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Pacific Cancer Care

Monterey, CA United States
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University of Cincinnati

Cincinnati, OH United States
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Clovis Oncology Clinical Trial Information

Nizhny Novgorod, Russian Federation
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Clovis Oncology Clinical Trial Information

Saint Petersburg, Russian Federation
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Clovis Oncology Clinical Trial Information

Saint-Petersburg, Russian Federation
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Clovis Oncology Clinical Trial Information

Newcastle upon Tyne, United Kingdom
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Velindre NHS Trust

Cardiff, United Kingdom
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Recruitment Status: Open


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