RECRUITING

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

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Conditions

Ovarian CancerINCB123667

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08-30
Study Completion:2027-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07023627

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  2. * Have platinum-resistant disease:
  3. * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * Must have received bevacizumab unless there was a contraindication for its use.
  8. * If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
  1. * Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
  2. * 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.
  3. * The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
  4. * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
  5. * Known active CNS metastases and/or carcinomatous meningitis.
  6. * Known additional malignancy that is progressing or requires active treatment.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Usa Health Mitchell Cancer Institute
Mobile, Alabama, 36604
United States
Uams Winthrop P Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90024-6995
United States
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California, 92103
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Northeast Georgia Medical Center Gainesville
Gainesville, Georgia, 30501
United States
Parkview Research Center
Fort Wayne, Indiana, 46845
United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250
United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242-1009
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Trials365, Llc
Shreveport, Louisiana, 71133
United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
St Joseph Mercy Hospital-Gynecologic Oncology Clinic
Ypsilanti, Michigan, 48197
United States
Minnesota Oncology-Minneapolis
Minneapolis, Minnesota, 55404
United States
St. Vincent Regional Hospital - West End Clinic
Billings, Montana, 59106
United States
Methodist Hospital Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
State University of New York Upstate Medical Unive
Syracuse, New York, 13210
United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45242
United States
The Mark H Zangmeister Cancer Center Ohio
Columbus, Ohio, 43219
United States
Kaiser Permanente Center For Health Research
Portland, Oregon, 97227
United States
Asplundh Cancer Pavilion - Thomas Jefferson
Willow Grove, Pennsylvania, 19090
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Texas Oncology-Austin Center
Austin, Texas, 78731
United States
Houston Methodist Cancer Center
Houston, Texas, 77030
United States
Cancer Care Center of South Texas-Medical Center
San Antonio, Texas, 78229
United States
Texas Oncology-Tyler
Tyler, Texas, 75702
United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106
United States
Virginia Cancer Specialists, Pc
Fairfax, Virginia, 22031
United States
Carilion Clinic
Roanoke, Virginia, 24016-4962
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-30
Study Completion Date2027-10-24

Study Record Updates

Study Start Date2025-08-30
Study Completion Date2027-10-24

Terms related to this study

Keywords Provided by Researchers

  • INCB123667

Additional Relevant MeSH Terms

  • Ovarian Cancer