A PHASE 1b STUDY OF ZN-c3 IN COMBINATION WITH CHEMOTHERAPY OR BEVACIZUMAB IN SUBJECTS WITH OVARIAN, PERITONEAL, OR FALLOPIAN TUBE CANCER

Primary Objective

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.

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Description

This study plans to learn more about an investigational drug called ZN-c3 (also known as azenosertib; KP-2638). Investigational means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). ZN-c3 may be called the study drug. The purpose of this study includes the following: To test the safety and tolerability of different doses of the study drug tablets in combination with carboplatin, paclitaxel, PLD, gemcitabine and to find out what effects, good and/or bad, it has on you and your cancer. To choose which dose amount of the study drug that should be studied in future studies. To identify which dose of the study drug to be used in this study is the highest dose that subjects can receive without having severe symptoms. To understand how the body absorbs and processes different doses of the study treatment by measuring their amount in the blood before, during, and after receiving the study treatment - This is called pharmacokinetics (PK) testing. This study will involve the use of five different medications: 1. The study drug 2. Carboplatin 3. Pegylated liposomal doxorubicin (PLD) 4. Paclitaxel 5. Gemcitabine Carboplatin, paclitaxel, PLD, and gemcitabine are anti-cancer medications that are used for the treatment of ovarian, peritoneal, or fallopian tube cancer and other types of cancers. These drugs have been approved for this use by the U.S. Food and Drug Administration (FDA) and other regulatory authorities. You will not receive all five medications. You will either receive the study drug with carboplatin, the study drug with paclitaxel, the study drug with PLD, or the study drug with gemcitabine. These are called combinations where you are being given a combination of more than one drug to treat your cancer. Your study doctor will decide which treatment combination is best for you. This study is being done to determine if adding the study drug to either carboplatin, paclitaxel, PLD, or gemcitabine is safe and whether it will slow or stop the spread of your cancer. You are being asked to be in this research study because you have been diagnosed with ovarian, peritoneal, or fallopian tube cancer that has spread and has not responded to treatment with other chemotherapy agents including carboplatin or cisplatin. You must have received carboplatin or cisplatin for you to be considered in this study. One other criterion is that while you were receiving carboplatin or cisplatin, your cancer was not controlled.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Bradley Corr

Bradley Corr

Study ID

Protocol Number: 22-0890

More information available at ClinicalTrials.gov: NCT04516447

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