RECRUITING

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Description

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Conditions

Study Overview

Study Details

Study overview

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Mobile

Usa Health Mitchell Cancer Institute, Mobile, Alabama, United States, 36604

Little Rock

Uams Winthrop P Rockefeller Cancer Institute, Little Rock, Arkansas, United States, 72205

Los Angeles

University of California, Los Angeles Medical Center, Los Angeles, California, United States, 90024-6995

San Diego

Scripps Healthscripps Mercy Hospital Prebys Cancer Center, San Diego, California, United States, 92103

Miami Beach

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Gainesville

Northeast Georgia Medical Center Gainesville, Gainesville, Georgia, United States, 30501

Fort Wayne

Parkview Research Center, Fort Wayne, Indiana, United States, 46845

Indianapolis

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

Indianapolis

Community Health Network, Inc., Indianapolis, Indiana, United States, 46250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histological diagnosis of a 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 a 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 therapy is considered an appropriate next therapeutic option.
  • * Must have received bevacizumab unless there was a contraindication for its use.
  • * If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
  • * 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: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
  • * The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
  • * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
  • * Known active CNS metastases and/or carcinomatous meningitis.
  • * Known additional malignancy that is progressing or requires active treatment.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-10-24