Ovarian Cancer Clinical Trial
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
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.
Full 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.
Eligibility Criteria
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
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There are 3 Locations for this study
Denver Colorado, 80218, United States
Augusta Georgia, 30912, United States
Fortaleza Ceara, , Brazil
Curitiba Parana, , Brazil
Porto Alegre RIO Grande DO SUL, , Brazil
Florianópolis Santa Catarina, , Brazil
Barretos SAO Paulo, , Brazil
Rio de Janeiro , , Brazil
Sao Paulo , , Brazil
Sao Paulo , , Brazil
Calgary Alberta, , Canada
Ottawa Ontario, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Sherbrooke Quebec, , Canada
Brno Jihormoravsky KRAJ, , Czechia
Praha 5 Praha, , Czechia
Ostrava , , Czechia
Praha , , Czechia
Debrecen Hajdu-bihar, , Hungary
Budapest , , Hungary
Haifa , , Israel
Holon , , Israel
Jerusalem , , Israel
Petach-Tikva , , Israel
Ramat Gan , , Israel
Tel Aviv , , Israel
Bologna , , Italy
Candiolo , , Italy
Catania , , Italy
Milano , , Italy
Milano , , Italy
Modena , , Italy
Napoli , , Italy
Roma , , Italy
Grzybnica West Pomeranian Voivodeship, , Poland
Bialystok , , Poland
Lublin , , Poland
Olsztyn , , Poland
Poznan , , Poland
Szczecin , , Poland
Arkhangelsk , , Russian Federation
Kursk , , Russian Federation
Moscow , 11547, Russian Federation
Omsk , , Russian Federation
Pyatigorsk , , Russian Federation
Ryazan , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saransk , , Russian Federation
Sochi , , Russian Federation
Ufa , , Russian Federation
Barcelona , , Spain
Barcelona , , Spain
Girona , , Spain
La Coruna , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Dnipropetrovsk , , Ukraine
Kyiv , , Ukraine
Lutsk , , Ukraine
Lviv , , Ukraine
Sumy , , Ukraine
Uzhgorod , , Ukraine
Manchester England, , United Kingdom
Sutton Surrey, , United Kingdom
Cambridge , , United Kingdom
Cardiff , , United Kingdom
Coventry , , United Kingdom
Derby , , United Kingdom
Glasgow , , United Kingdom
London , , United Kingdom
Middlesex , , United Kingdom
Newcastle upon Tyne , , United Kingdom
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