A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib in Subjects with Platinum-Resistant Ovarian Cancer

UVA Tracking #
HSR220067
Principal Investigator
Linda R Duska
Contact
Linda Duska
Contact Phone
434.924.5100
Official Trial Title
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib in Subjects with Platinum-Resistant Ovarian Cancer
Study Description

The University of Virginia Comprehensive Cancer Center seeks women ages 18 and over with ovarian cancer to participate in a research study. The purpose of the study is to evaluate an investigational drug called ZN-c3 when given combination with niraparib at different dose levels, and identify which dose of ZN-c3 in combination with niraparib is the best dose that subjects can receive while trying to minimize severe symptoms, as well as looking at how your ovarian cancer responds to ZN-c3 in combination with niraparib.

You may be eligible for this study if you have been diagnosed with ovarian cancer that has spread and has not responded to treatment with standard chemotherapy agents and has come back following maintenance therapy with a Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor drug.

The study involves taking the investigational drug (ZN-c3) and niraparib daily, as well as coming in for study visits which include exams, laboratory tests, and procedures such as having your blood drawn, talking to the study doctor, and answering questionnaires. Participation includes a screening visit, 1-6 visits per cycle during treatment, an end of treatment visit and safety follow-up visit, and an additional follow-up period via phone calls to keep track of how you are doing. Treatment cycles for this study are 28 days. There is an unlimited amount of cycles in this study.

The investigational drugs, ZN-c3 and Niraparib, as well as study related doctor's visits and laboratory tests, will be provided at no cost to you.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05198804

Compensation

You will be paid $50 per visit