About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- azenosertib