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

Other illness

• A serious illness or medical condition(s)
• Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • Additional protocol-defined exclusion criteria may apply

Other

• Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
• Subjects with carcinosarcomas (even if there is a serous component)

• 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:
• In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
• In the 2L setting:
  • Progressive Disease \>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
  • 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