RECRUITING

A Study of ZN-c3 in Patients With Ovarian Cancer

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Conditions

Solid TumorEpithelial Ovarian CancerFallopian Tube CancerPeritoneal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2020-10-26
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04516447

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
  2. * Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
  3. * Measurable disease per RECIST version 1.1.
  4. * Adequate hematologic and organ function as defined by the following criteria:
  5. 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.
  6. 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.
  7. 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.
  8. 4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
  9. 5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
  1. * Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
  2. * Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
  3. 1. Major surgery within 28 days.
  4. 2. Radiation therapy within 21 days.
  5. 3. Autologous or allogeneic stem cell transplant within 3 months.
  6. 1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.
  7. 2. Myocardial impairment of any cause.
  8. 3. Significant gastrointestinal abnormalities.
  9. 4. Active or uncontrolled infection.
  10. 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.
  11. * Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

Contacts and Locations

Study Contact

K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
CONTACT
8582634333
medicalaffairs@zentalis.com

Study Locations (Sites)

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

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-26
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2020-10-26
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • Solid Tumor

Additional Relevant MeSH Terms

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