A Study of ZN-c3 in Patients With Ovarian Cancer

Launched by K-GROUP, BETA, INC., A WHOLLY OWNED SUBSIDIARY OF ZENTALIS PHARMACEUTICALS, INC · Aug 14, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ZN-c3 for women with advanced ovarian cancer, fallopian tube cancer, or peritoneal cancer. It's a Phase 1 study, which means it's one of the first steps in testing this treatment in people. Researchers want to find out if ZN-c3 is safe to use, how well it works when combined with other drugs, and how the body processes it. The trial is currently recruiting participants, focusing on women aged 65 to 74 who have already tried one or two previous treatments for their cancer.

To be eligible for this study, participants need to have a specific type of ovarian cancer that has been confirmed by medical tests and must have measurable disease as determined by standard guidelines. Additionally, they should have good overall health, including stable blood counts and organ function. Those with certain serious health issues or recent treatments may not qualify. Participants in this study can expect to receive close monitoring and care throughout the trial, helping researchers gather important information about this new treatment option.

Gender

FEMALE

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:
• • 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.
• 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:
• • 1. Major surgery within 28 days.
• • 2. Radiation therapy within 21 days.
• • 3. Autologous or allogeneic stem cell transplant within 3 months.
• A serious illness or medical condition(s) including, but not limited to, the following:
• • 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.