A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fal… (NCT05128825) | Clinical Trial Compass
RecruitingPhase 2
A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
United States310 participantsStarted 2022-02-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Prior therapy:
✓. Subjects must have platinum-resistant disease
✓. Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
✓. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol
✓. Prior bevacizumab treatment is required, if eligible per standard of care
Exclusion criteria
✕. 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
✕. Any of the following treatment interventions within the specified time frame prior to C1D1:
✕. Major surgery within 28 days
What they're measuring
1
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]
Timeframe: Up to approximately 12 months from the enrollment of the last subject
Trial details
NCT IDNCT05128825
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc