A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Inclusion Criteria

• INCLUSION CRITERIA: For Part 1: - Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma. - Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin. - The disease must be platinum resistant (ie, the PFI must have been < 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed. For Part 2 Dose Escalation: Prior therapy: • Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy Response to prior platinum therapy: 1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy. 2. In the 2L setting: 1. Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting, 2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy. - Adequate hematologic, and organ function For Part 2 Dose Expansion: - Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease - Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply EXCLUSION CRITERIA: - Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor. - Subjects with carcinosarcomas (even if there is a serous component) - A serious illness or medical condition(s) - Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. Additional protocol-defined exclusion criteria may apply