ARIEL4: Rucaparib and Recurrent Ovarian Cancer
Study Contact Information:
Questions about the study should be directed to Clovis Oncology Clinical Trial Navigation Service at: 1-855-262-3040 or by email
The study is open and recruiting at sites in these state: AZ, CA, CO, FL, ME, MI, NY, OH and these countries: Canada, Czechia, Brazil, Hungary, Israel, Italy, Poland, Spain, Ukraine, United Kingdom
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
About the Study
ARIEL4 is a treatment study for women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a BRCA1 or BRCA2 mutation. ARIEL4 is designed to evaluate rucaparib against standard of care chemotherapy in women who have had at least two prior chemotherapy regimens. Visit the ARIEL4 Study page for more information.
Type of Study
ARIEL4 is a randomized, 2-arm, open-label cross-over study.
- This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. This is a 2:1 randomized study. This means that patients will have a slightly greater chance of being placed in the treatment group than the standard treatment group.
- The study has 2 arms. This means that patients in the study are placed in one of two different groups. One group will received the PARP inhibitor rucaparib and the other group will receive one of several standard chemotherapy treatment options chosen by their oncologist.
- The study is open-label. All participating patients will know which group they have been assigned to.
- The study allows crossover. this means that patients who progress on the standard treatment arm will be given the opportunity to crossover into the rucaparib arm if they choose.
What the Study Entails
- Patients chosen to be on the rucaparib arm will receive oral rucaparib twice daily.
- Patients chosen to be on the chemotherapy arm will receive one of several standard of care chemotherapy options as chosen by their doctor.
Patient who qualify for the ARIEL4 trial and enroll, receive the following as part of the study: standard-of-care and study related clinical exams, blood tests, imaging scans of your cancer, lab test results including BRCA and the other biomarker tests, the study medication (rucaparib or chemotherapy) and other assessments. Patients who were treated with chemotherapy on the main study and then experience a worsening of their ovarian cancer may be eligible to receive rucaparib after they discontinue chemotherapy.
Study sites are open in several states in the US and international sites are open as well. For an up-to-date list of study sites, visit the ARIEL4 website.
|Arizona||Tucson||University of Arizona cancer CenteAllison Wolgast (Study Coordinator) by phone: 1-313-576-8994 or by emailr||Yrma Burruel (Study Coordinator) by phone: 1-520-694-9081 or by email|
|Elizabeth (Jennie) Collins (Study Coordinator) by phone: 1-520-694-9067 or by email|
|California||Monterey||Pacific Cancer Care||Leslie Hohenbrink (Study Coordinator) by phone: 1-831-375-4105 or by email|
|Orange||University of California Irvine Health Chao Family Comprehensive Cancer Center||Anita Wallick (Study Coordinator) by phone: 1-714-456-6191 or by email|
|Colorado||Littleton||Rocky Mountain Cancer Center||Valerie Apodaca by phone: 1-303-285-5081 or by email|
|Florida||Orlando||Florida Hospital Cancer Institute||Jane LeBlanc (Study Coordinator) by phone: 1-407-303-2090, ext: 1104286 or by email|
|Maine||Scarborough||Maine Medical Center Maine Medical Partners Gynecologic Oncology||Robin Donovan (Study Coordinator) by phone: 1-207-396-7089 or by email|
|Michigan||Detroit||Wayne State University||Allison Wolgast (Study Coordinator) by phone: 1-313-576-8994 or by email|
|New York||Mineola||Women's Contemporary Care Associates (WCCA) – Mineola||Jennifer Brown (Study Coordinator) by phone: 1-516-663-3115 or by email|
|Ohio||Cincinnati||University of Cincinnati||Lisa Woeste (Study Coordinator) by phone: 1-513-584-4528 or by email|
International Study Sites:
Canada, Czechia, Brazil, Hungary, Israel, Italy, Poland, Spain, Ukraine, United Kingdom
Women with ovarian cancer who:
- 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
Patients will be excluded if:
- they have a history of prior cancers except for those that have been curatively treated, with no evidence of cancer currently
- they have a history of prior treatment with any PARP inhibitor
- they have a history of symptomatic and/or untreated central nervous system metastases
- they have a history of hospitalization for bowel obstruction within 3 months prior to enrollment