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

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

FACILITYZIPCITYSTATE
Usa Health Mitchell Cancer Institute36604MobileAlabama
Uams Winthrop P Rockefeller Cancer Institute72205Little RockArkansas
University of California, Los Angeles Medical Center90024-6995Los AngelesCalifornia
Scripps Healthscripps Mercy Hospital Prebys Cancer Center92103San DiegoCalifornia
Medstar Georgetown University Hospital20010Washington D.C.District of Columbia
Florida Cancer Specialists & Research Institute33901Fort MyersFlorida
Mayo Clinic32224JacksonvilleFlorida
Sylvester Comprehensive Cancer Center33136MiamiFlorida
Mount Sinai Comprehensive Cancer Center33140Miami BeachFlorida
Florida Cancer Specialists & Research Institute33401West Palm BeachFlorida

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.