A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer (NCT05198804) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer
United States117 participantsStarted 2022-01-27
Plain-language summary
This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
✓. Subjects must have platinum-resistant disease.
✓. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
✓. Adequate hematologic and organ function.
✓. Ability and willingness to take oral medication.
✓. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.
Exclusion criteria
✕. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C).
✕. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
✕. Any investigational drug therapy \<28 days.
✕. Prior treatment with a WEE1 inhibitor.
✕. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
✕
What they're measuring
1
To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D
Timeframe: 6 months
2
To determine the safety and tolerability of ZN-c3 monotherapy
Timeframe: 12 months
3
To investigate the antitumor activity of ZN-c3 monotherapy
Timeframe: 12 months
Trial details
NCT IDNCT05198804
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
✕. Uncontrolled hypertension (Diastolic BP \> 90 mmHg or Systolic BP \> 140 mmHg).
✕. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV).