Ovarian Cancer Tesaro (FIRST)

ENGOT-0V44 The FIRST (First-line Ovarian Cancer Treatment With Niraparib Plus TSR-042) Study: A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

This is a global, multicenter, randomized, double-blind, controlled Phase 3 study in patients with newly diagnosed, Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer"). The currently recommended standard of care therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab.

Eligibility Criteria

• Patients with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, an mixed pathologies) that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.
• All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo primary debulking surgery (complete cytoreduction (CC0) or macroscopic disease), or those for whom neoadjuvant chemotherapy is planned.
• Patients with Stage III are eligible if they meet one or more of the following criteria:

• High risk Stage IIIC disease.
• Planning to receive neoadjuvant chemotherapy.
• Patients must provide a blood sample for research at Screening.

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut