A Study of ZN-c3 in Patients With Ovarian Cancer

Description

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.

Conditions

Solid Tumor, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer

A Study of ZN-c3 in Patients With Ovarian Cancer

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Aurora

Site 0264, Aurora, Colorado, United States, 80045

Boston

Site 0104, Boston, Massachusetts, United States, 02215

Saint Louis

Site 0111, Saint Louis, Missouri, United States, 53110

New York

Site 0173, New York, New York, United States, 10029

Durham

Site 0259, Durham, North Carolina, United States, 27710

Providence

Site 0191, Providence, Rhode Island, United States, 02905

Nashville

Site 0196, Nashville, Tennessee, United States, 37203

Houston

Site 0103, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
  • 5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
  • * 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:
  • 1. Major surgery within 28 days.
  • 2. Radiation therapy within 21 days.
  • 3. Autologous or allogeneic stem cell transplant within 3 months.
  • 1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.
  • 2. Myocardial impairment of any cause.
  • 3. Significant gastrointestinal abnormalities.
  • 4. Active or uncontrolled infection.
  • 5. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Study Record Dates

2027-02-28