Status:
RECRUITING
A Study of ZN-c3 in Patients With Ovarian Cancer
Lead Sponsor:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions:
Solid Tumor
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 dru...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
- Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced 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 platelets 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.
Exclusion
- Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
- Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
- Major surgery within 28 days.
- Radiation therapy within 21 days.
- Autologous or allogeneic stem cell transplant within 3 months.
- A serious illness or medical condition(s) including, but not limited to, the following:
- Brain metastases that require immediate treatment or are clinically or radiographically unstable.
- Myocardial impairment of any cause.
- Significant gastrointestinal abnormalities.
- Active or uncontrolled infection.
- Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.
- Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04516447
Start Date
October 26 2020
End Date
February 28 2027
Last Update
November 26 2024
Active Locations (24)
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1
Site 0264
Aurora, Colorado, United States, 80045
2
Site 0104
Boston, Massachusetts, United States, 02215
3
Site 0111
St Louis, Missouri, United States, 53110
4
Site 0173
New York, New York, United States, 10029