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

INCLUSION CRITERIA:

For Part 1:

1. Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
2. 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.
3. 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:

1. 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:

1. Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
2. Subjects with carcinosarcomas (even if there is a serous component)
3. A serious illness or medical condition(s)
4. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

Additional protocol-defined exclusion criteria may apply