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

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

This is a Phase 1b open-label, multicenter study evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (also known as ZN-c3) in combination with chemotherapy or bevacizumab. This study consists of 2 parts: Part 1 (completed and no longer recruiting): Azenosertib in combination with chemotherapy Azenosertib was assessed in combination with chemotherapy in subjects with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer. Part 2: Azenosertib in combination with bevacizumab * Dose Escalation (completed and no longer recruiting): Azenosertib was assessed in combination with bevacizumab as first-line (1L) or second-line (2L) maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy to determine a recommended dose for expansion. * Dose Expansion: Azenosertib will be assessed in combination with bevacizumab as 2L maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy.

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