Study on ZN-c3 and Niraparib for Patients with Platinum-Resistant Ovarian Cancer

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05198804

Provider View

This clinical trial is testing a new treatment using the drugs ZN-c3 and Niraparib for patients with ovarian cancer that has not responded to platinum-based chemotherapy. The study aims to evaluate the safety and effectiveness of these drugs, both together and separately.

Patient Parameters

Program Overview

This study is exploring a new treatment for ovarian cancer that has not responded to platinum-based chemotherapy. The treatment involves using two drugs, ZN-c3 and Niraparib, to see if they can help control the cancer. The study will look at how safe these drugs are, how well they work, and how they behave in the body. Participants will receive either the combination of both drugs or ZN-c3 alone, and researchers will monitor their health and the cancer's response to the treatment.

Description

This clinical trial is designed to test the safety and effectiveness of a new treatment for ovarian cancer that has become resistant to platinum-based chemotherapy. The study involves two drugs: ZN-c3 and Niraparib. Researchers want to see if these drugs can help control the cancer when used together or if ZN-c3 can work on its own. Participants will be monitored closely to see how their bodies respond to the treatment and to check for any side effects. The study will take place at multiple centers, and participants will need to provide a sample of their tumor for analysis.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of recurrent high-grade ovarian, primary peritoneal, or fallopian tube cancer with specific subtypes (serous, clear cell, or endometrioid) and no other curative treatment options.
  • The cancer must be resistant to platinum-based chemotherapy.
  • Must have at least one tumor that can be measured by scans or tests.
  • Have good blood and organ function as shown by medical tests.
  • Be able to take oral medication.
  • Provide a tumor sample from the primary or recurrent cancer for analysis.

Exclusion Criteria

  • Have received any cancer treatment within the last four weeks before starting the study (six weeks for certain drugs).
  • Must wait at least 10 days after stopping previous PARP inhibitor treatment before starting the study drugs.
  • Have taken any experimental drugs within the last 28 days.
  • Have previously been treated with a WEE1 inhibitor.
  • Have allergies to drugs similar to ZN-c3 or Niraparib.
  • Have a history or current diagnosis of certain blood disorders like myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Have uncontrolled high blood pressure.
  • Have heart problems that cause heart failure.
  • Have significant digestive issues that affect absorption or require IV feeding.
  • Have an abnormal heart rhythm as shown by an ECG test.
  • Have a family history of certain heart rhythm disorders.
  • Are taking medications known to cause heart rhythm problems.

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