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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04516447

Recruitment Status:

Recruiting

Sponsor:

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 22 Locations for this study

See Locations Near You

Site 0264
Aurora Colorado, 80045, United States
Site 0104
Boston Massachusetts, 02215, United States
Site 0111
Saint Louis Missouri, 53110, United States
Site 0173
New York New York, 10029, United States
Site 0259
Durham North Carolina, 27710, United States
Site 0191
Providence Rhode Island, 02905, United States
Site 0196
Nashville Tennessee, 37203, United States
Site 0103
Houston Texas, 77030, United States
Site 2707
South Brisbane Queensland, 4101, Australia
Site 2708
Sunshine Coast Queensland, 4556, Australia
Site 2709
Adelaide South Australia, 5000, Australia
Site 2706
Melbourne Victoria, 3144, Australia
Site 2705
Nedlands Western Australia, 6009, Australia
Site 1001
Banja Luka , 78000, Bosnia and Herzegovina
Site 1002
Sarajevo , 71000, Bosnia and Herzegovina
Site 1003
Tuzla , 75000, Bosnia and Herzegovina
Site 1202
Panagyurishte , 4500, Bulgaria
Site 1201
Sofia , 1632, Bulgaria
Site 1401
Tbilisi , 0112, Georgia
Site 2901
Busan , , Korea, Republic of
Site 2903
Seoul , 03080, Korea, Republic of
Site 2904
Seoul , 05505, Korea, Republic of
Site 1902
Belgrade , 11080, Serbia

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04516447

Recruitment Status:

Recruiting

Sponsor:


K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.