Ovarian Cancer Clinical Trial
A Study of ZN-c3 in Patients With Ovarian Cancer
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 drugs.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 22 Locations for this study
Aurora Colorado, 80045, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 53110, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Providence Rhode Island, 02905, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
South Brisbane Queensland, 4101, Australia
Sunshine Coast Queensland, 4556, Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3144, Australia
Nedlands Western Australia, 6009, Australia
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Tuzla , 75000, Bosnia and Herzegovina
Panagyurishte , 4500, Bulgaria
Sofia , 1632, Bulgaria
Tbilisi , 0112, Georgia
Busan , , Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Belgrade , 11080, Serbia
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