Study Comparing Azenosertib to Chemotherapy for Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancers with Cyclin E1 Protein
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ClinicalTrials ID:NCT07546500
This clinical trial is testing a new drug, azenosertib, against standard chemotherapy in women with certain types of ovarian, peritoneal, or fallopian tube cancers that have not responded to platinum-based treatments and show a specific protein, Cyclin E1.
Patient Parameters
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Program Overview
This study aims to compare the effectiveness and safety of a new drug called azenosertib with standard chemotherapy in women with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based treatments. These cancers must show the presence of a protein called Cyclin E1. Azenosertib works by interfering with cancer cell division, potentially leading to cancer cell death.
Description
This Phase 3 study is designed to see if azenosertib (ZN-c3) is more effective and safer than standard chemotherapy for women with certain types of ovarian, peritoneal, or fallopian tube cancers that have not responded to platinum-based treatments. Azenosertib is a drug that targets a specific protein involved in cell division, which may help kill cancer cells. The study will compare azenosertib to chemotherapy chosen by the doctor to see which works better in shrinking tumors and improving patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Cancer must be measurable by scans.
- Good overall health with a performance status score of 0 or 1.
- Cancer must show Cyclin E1 protein.
- Must have cancer that is resistant to platinum-based treatments.
- Allowed 1 to 3 previous treatments (or up to 4 if previously treated with mirvetuximab).
- Must have had prior treatment with bevacizumab, PARP inhibitors (if applicable), and mirvetuximab (if applicable).
- Must have adequate blood and organ function.
Exclusion Criteria
- History of another cancer in the past 2 years, unless treated and disease-free.
- Cancer that did not respond to initial platinum-based treatment.
- Previous treatment with azenosertib or similar drugs.
- Serious medical conditions, including:
- Unstable brain cancer requiring immediate treatment.
- Severe kidney issues or need for a catheter.
- Significant digestive problems affecting medication intake.
- Recent or recurrent bowel obstruction.
- Active, uncontrolled infections.
- Heart failure.
- Any condition that increases risk or affects study results.
- Recent hospitalization, major surgery, or cancer treatments.
- Use of certain medications or supplements that cannot be stopped.
- Previous extensive radiation therapy.
- Unresolved side effects from past treatments.
- Immunocompromised or HIV-positive on certain therapies.
- Active hepatitis B or C infection.
- Judged unsuitable for the study by the doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Site 0107 | 85016 | Phoenix | Arizona |
| Site 0110 | 94531 | Antioch | California |
| Site 0115 | 94109 | San Francisco | California |
| Site 0101 | 90505 | Torrance | California |
| Site 0111 | 08103 | Camden | New Jersey |
| Site 0108 | 43026 | Columbus | Ohio |
| Site 0105 | 97210 | Portland | Oregon |
| Site 0109 | 19104 | Philadelphia | Pennsylvania |
| Site 0113 | 19111 | Philadelphia | Pennsylvania |
| Site 0114 | 19090 | Willow Grove | Pennsylvania |
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