Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Sponsor: Incyte Corporation

Sponsor score: 60

ClinicalTrials ID:NCT07214779

This clinical trial evaluates the efficacy of INCB123667 compared to investigator-selected chemotherapy in patients with platinum-resistant ovarian cancer exhibiting cyclin E1 overexpression. Eligible participants must have high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, with prior platinum-based therapy and measurable disease. Interventions include oral INCB123667 or chemotherapy per protocol.

Patient Parameters

Program Overview

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Eligibility Criteria

Inclusion Criteria

  • Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

  • Have platinum-resistant disease.

    • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
    • Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
  • Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.

  • Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.

  • Should have received prior treatment with bevacizumab unless there was a contraindication for its use.

  • Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.

  • Measurable disease per RECIST v1.1.

Exclusion Criteria

  • Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
  • Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
  • Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
  • Clinically significant gastrointestinal abnormalities.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations

FACILITYZIPCITYSTATE
Alaska Womens Cancer Care Akwcc99508AnchorageAlaska
City of Hope Medical Center91010DuarteCalifornia
Valkyrie Clinical Trials90067Los AngelesCalifornia
University of Colorado Cancer Center80045AuroraColorado
Georgia Cancer Center30912AugustaGeorgia
Carle Cancer Center62401-2006EffinghamIllinois
Northshore University Health System-Evanston Hospital60201EvanstonIllinois
Women'S Cancer Care70433CovingtonLouisiana
Maine Center For Cancer Medicine04074ScarboroughMaine
Holy Cross Hospital20910Silver SpringMaryland

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