Malignant tumor of fallopian tubes / Posted 3 years ago

ARIEL 4: A Phase 3 Multicenter, Open-label, Randomized Study of Rucaparib versus Chemotherapy in Patients with Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Globally, ovarian cancer is the eighth most common cancer and the seventh leading cause of cancer death among women. Cancer is caused by changes to genes that control the way our cells function. Chemical substances and other formulations are used in treatment. Chemotherapy is a treatment where chemical substances are used to damage and kill cancer cells. An enzyme inhibitor is a molecule that binds to an enzyme, to help slow down a reaction or to prevent unwanted change. Inhibitors are used in cancer treatments for that purpose. Rucaparib is a molecule inhibitor of enzymes. The main purpose of this study is to evaluate safety, disease status and progression-free survival of Rucaparib versus standard chemotherapy for treatment of certain ovarian, fallopian tube and primary peritoneal cancers with specific changes in certain gene cells. Patients aged 18 years and older with these cancers may be eligible to take part and will be enrolled onto the study to receive randomly either Rucaparib or chemotherapy. Participants receiving chemotherapy will receive either paclitaxel or the investigators choice of chemotherapy. Rucaparib will be given orally on a daily basis in 28 day cycles and chemotherapy will be given intravenously (into a vein). Some chemotherapy treatment will be given up to a maximum of 8 cycles. Participants who are randomly assigned to receive chemotherapy may crossover to receive rucaparib if their disease worsens. All other participants and those who crossover, continue with treatment cycles until the disease progresses. This study will take place at oncology clinics, within hospital settings.

  • Inclusion Criteria :
    • 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
  • Exclusion Criteria : 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
  • Study start date : 01/09/2016
  • Study end date : 01/06/2022
  • Wales-Based Study Contact : please speak to your clinician

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