Ireland
--:--IST
Recruiting Phase 3

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

NCT07214779 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2025-12-09
Last updated
2026-10-15

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

INCB123667 →Investigator's choice of chemotherapy

INCB123667: Oral; tablet

Investigator's choice of chemotherapy: The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) by BICR — Up to 2 years
    Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
  • Overall Survival (OS) — Up to 2 years
    Defined as the time from the date of randomization until death due to any cause.

Trial sites (198)

FacilityCityRegionStatus
Alaska Womens Cancer Care Akwcc Anchorage Alaska Completed
University of Arizona Cancer Center Tucson Arizona Completed
City of Hope Medical Center Duarte California Recruiting
Providence Medical Foundation Fullerton California Completed
University of California, San Diego-Moores Cancer Center La Jolla California Completed
Valkyrie Clinical Trials Los Angeles California Recruiting
Uci Health Chao Family Comprehensive Cancer Center Orange California Completed
Ventura County Hematology Oncology Specialists-Oxnard Oxnard California Completed
University of Colorado Cancer Center Aurora Colorado Completed
Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida Not Yet Recruiting
Brcr Global Miramar Florida Completed
Sarasota Memorial Health Care System Sarasota Florida Completed
Winship Cancer Institute At Emory University Atlanta Georgia Completed
Georgia Cancer Center Augusta Georgia Completed
The University of Chicago Medicine Chicago Illinois Completed
Carle Cancer Center Effingham Illinois Completed
Northshore University Health System-Evanston Hospital Evanston Illinois Completed
City of Hope - Chicago Cancer Center Zion Illinois Completed
St Elizabeth Healthcare Edgewood Kentucky Completed
Women'S Cancer Care Covington Louisiana Not Yet Recruiting
Trials365, Llc Shreveport Louisiana Not Yet Recruiting
Maine Center For Cancer Medicine Scarborough Maine Completed
Holy Cross Hospital Silver Spring Maryland Completed
Greater Baltimore Medical Center Towson Maryland Not Yet Recruiting
Henry Ford Cancer - Detroit Detroit Michigan Completed
Mercy Hospital St. Louis - David C. Pratt Cancer Center St Louis Missouri Completed
Billings Clinic Billings Montana Recruiting
Women'S Cancer Center of Nevada Las Vegas Nevada Completed
Center of Hope Reno Nevada Completed
Maimonides Medical Center Short Hills New Jersey Not Yet Recruiting
Unm Comprehensive Cancer Center Albuquerque New Mexico Completed
Levine Cancer Center Charlotte North Carolina Not Yet Recruiting
Novant Presbyterian Hospital Charlotte North Carolina Recruiting
East Carolina University Greenville North Carolina Completed
Novant Health Oncology Specialists Winston-Salem North Carolina Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Not Yet Recruiting
Cleveland Clinic Foundation Cleveland Ohio Completed
Ohio Health Research Institute Columbus Ohio Completed
Miami Valley Hospital South Dayton Ohio Completed
Promedica Flower Hospital Sylvania Ohio Completed

+ 158 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07214779 on ClinicalTrials.gov ↗ ← All trials in Japan