ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Condition: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Chemotherapy; Rucaparib
Intervention description: Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.; Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Rucaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 349.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; fallopian tube cancer; primary peritoneal cancer; peritoneal cancer; platinum sensitive; relapsed disease; PARP Inhibitor; PARP; rucaparib; ruca; homologous recombination; homologous recombination deficiency; genomic scarring; loss of heterozygosity; CO-338; PF-01367338; PF 01367338; CO-338-043; platinum sensitive ovarian cancer; platinum sensitive fallopian tube cancer; platinum sensitive primary peritoneal cancer; platinum sensitive peritoneal cancer; gynecological cancer; Clovis; Clovis oncology; ARIEL2; ARIEL 2; ARIEL-2; ARIEL-3; ARIEL 3; ARIEL3; ARIEL4; ARIEL-4; ARIEL 4; A4; advanced OC; platinum resistant ovarian cancer; platinum resistant primary ovarian cancer; Rubraca; High grade serous; Partially platinum sensitive

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.
    

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