Study on INCB123667 for Treating Platinum-Resistant Ovarian Cancer with High Cyclin E1 Levels
Sponsor: Incyte Corporation
Sponsor score: 60
ClinicalTrials ID:NCT07023627
This clinical trial is testing a new drug, INCB123667, to see if it is safe and effective for women with ovarian cancer that has not responded to platinum-based treatments and shows high levels of a protein called Cyclin E1.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug, INCB123667, in women with ovarian cancer that has become resistant to platinum-based chemotherapy and has high levels of Cyclin E1, a protein that can affect cancer growth.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
- Cancer must be resistant to platinum-based treatments:
- If only one round of platinum treatment was received, it must have included at least four cycles.
- If two to four rounds of platinum treatment were received, the cancer must have worsened during or within six months after the last treatment.
- Willing to have a biopsy before starting the study. A recent tissue sample is preferred, but an older sample (up to five years old) is acceptable.
- Have had at least one but no more than four previous treatments since diagnosis, and single-agent therapy is the next suitable option.
- Must have received the drug bevacizumab unless it was not suitable for medical reasons.
- If the tumor is positive for FRα, must have received mirvetuximab soravtansine unless medically exempt.
Exclusion Criteria
- Have a type of ovarian cancer that is endometrioid, clear cell, mucinous, sarcomatous, or low-grade/borderline, or a mixed tumor with these types.
- Have primary platinum-refractory disease, meaning the cancer did not respond to the first platinum treatment or worsened within three months after the last dose.
- If the tumor is positive for FRα but the participant has not received mirvetuximab soravtansine for reasons other than medical exemption.
- Have significant or uncontrolled heart disease within six months before starting the study.
- Have active cancer spread to the brain or spinal cord.
- Have another progressing cancer that needs treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Usa Health Mitchell Cancer Institute | 36604 | Mobile | Alabama |
| Uams Winthrop P Rockefeller Cancer Institute | 72205 | Little Rock | Arkansas |
| University of California, Los Angeles Medical Center | 90024-6995 | Los Angeles | California |
| Scripps Healthscripps Mercy Hospital Prebys Cancer Center | 92103 | San Diego | California |
| Medstar Georgetown University Hospital | 20010 | Washington D.C. | District of Columbia |
| Florida Cancer Specialists & Research Institute | 33901 | Fort Myers | Florida |
| Mayo Clinic | 32224 | Jacksonville | Florida |
| Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Mount Sinai Comprehensive Cancer Center | 33140 | Miami Beach | Florida |
| Florida Cancer Specialists & Research Institute | 33401 | West Palm Beach | Florida |
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