This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
Age ≥18 years
High-grade serous ovarian, fallopian tube or primary peritoneal cancer
Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
Subjects must have platinum-resistant disease
Primary platinum-refractory disease
Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
Major surgery within 28 days
Hospitalization within 14 days
Parallel
azenosertib
DrugAzenosertib (ZN-c3) will be administered orally.
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Duration of response (DOR) defined by RECIST v1.1 [Part 2]
Time from the date of first documented response (CR or PR that is subsequently confirmed per RECIST v1.1) until the date of progressive disease (PD) or death.
Progression free survival (PFS) defined by RECIST v1.1 [Part 2]
Time from the date of first dose until the date of PD or death.
Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]
The percentage of participants who have at least 1 confirmed response of CR or PR, or stable disease for at least 16 weeks before any evidence of progression.
CA-125 response by GCIG criteria [Part 2]
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline.
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