Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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.

Official Title

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Keywords

Ovarian Cancer, INCB123667, Ovarian Neoplasms, Paclitaxel, liposomal doxorubicin, Gemcitabine, Topotecan

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • University of California, San Diego-Moores Cancer Center not yet accepting patients
    La Jolla California 92037 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • City of Hope Medical Center not yet accepting patients
    Duarte California 91010 United States
  • Billings Clinic accepting new patients
    Billings Montana 59101 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
ID
NCT07214779
Phase
Phase 3 Ovarian Cancer Research Study
Study Type
Interventional
Participants
Expecting 466 study participants
Last Updated