Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Rucaparib; Placebo
Intervention description: Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.; Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Intervention MeSH terms: Rucaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 564.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ARIEL3; ARIEL 3; platinum sensitive; PARP Inhibitor; rucaparib; homologous recombination; homologous recombination deficiency; CO-338; PF 01367338; AG 14699; platinum sensitive ovarian cancer; platinum sensitive fallopian tube cancer; platinum sensitive primary peritoneal cancer; platinum sensitive peritoneal cancer; gynecological cancer; Clovis; Clovis Oncology

Summary:

      Patients enrolled into this study will be stratified into 3 groups based on gene mutations
      identified in their tumor tissue. The purpose of this study is to evaluate patient response
      to maintenance treatment with rucaparib versus placebo. Response to treatment will be
      analyzed based on homologous recombination (HR) status of tumor samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary
             peritoneal, or fallopian tube cancer.

          -  Received ≥2 prior platinum-based treatment regimens including platinum based regimen
             that must have been administered immediately prior to maintenance therapy in this
             trial.

          -  Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will
             not be counted as a non-platinum regimen.

          -  Must have had at least a 6-month disease-free period following prior treatment with
             the penultimate platinum-based chemotherapy and achieved a response.

          -  For the last chemotherapy course prior to study entry, patients must have received a
             platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined
             by RECIST) and/or a GCIG CA-125 response.

          -  Have sufficient archival tumor tissue for analysis.

        Exclusion Criteria:

          -  History of prior cancer except for non-melanoma skin cancer, breast cancer curatively
             > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of
             recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer.

          -  Prior treatment with any PARP inhibitor, including rucaparib. Patients who received
             prior iniparib are eligible.

          -  Untreated or symptomatic central nervous system metastases.

          -  Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
             in the opinion of the Investigator, interfere with absorption of study drug.

          -  Required drainage of ascites during the final 2 cycles of their last platinum-based
             regimen and/or during the period between the last dose of chemotherapy of that regimen
             and randomization to maintenance treatment in this study.