A Study of ZN-c3 in Patients With Ovarian Cancer

Inclusion Criteria

• Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
• Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
• Measurable disease per RECIST version 1.1.
• Adequate hematologic and organ function as defined by the following criteria:
• ANC ≥ 1.5 × 10^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
• Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
• Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

Exclusion Criteria

• Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
• Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
• Major surgery within 28 days.
• Radiation therapy within 21 days.
• Autologous or allogeneic stem cell transplant within 3 months. A serious illness or medical condition(s) including, but not limited to, the following:
• Brain metastases that require immediate treatment or are clinically or radiographically unstable.
• Myocardial impairment of any cause.
• Significant gastrointestinal abnormalities.
• Active or uncontrolled infection.
• Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.
• Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.