Brief Summary
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.
Intervention / Treatment
- Drug: ZN-c3
- Drug: Carboplatin
- Drug: Pegylated liposomal doxorubicin
- Drug: Paclitaxel
- Drug: Gemcitabine
- Biological: Bevacizumab
Inclusion Criteria
- Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinomacancer arising from tissues that line organs, fallopian tube, or peritoneal carcinoma.
- Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advancedat a late stage, far along 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 plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding 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.