NCT02855944

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
DRUG	Rucaparib	Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-12-03
• Completion: 2022-09-16
• First posted: 2016-08-04
• Last updated: 2023-06-09
• Results posted: 2022-02-11

Locations

77 sites across 12 countries: United States, Brazil, Canada, Czechia, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study