Clinical Trials in Spain / NCT07023627
Recruiting
Phase 2
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
NCT07023627 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Ovarian Cancer
Investigational drug(s) / intervention(s)
INCB123667: Administered orally twice daily (BID).
Study summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Eligibility
Inclusion 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.
* Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.
* 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.
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: 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary outcome measure(s)
- Objective Response by IRC — Up to 2 years
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| Usa Health Mitchell Cancer Institute | Mobile | Alabama | Recruiting |
| University of California, Los Angeles Medical Center | Los Angeles | California | Recruiting |
| Scripps Healthscripps Mercy Hospital Prebys Cancer Center | San Diego | California | Recruiting |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | Recruiting |
| Florida Cancer Specialists & Research Institute | Fort Myers | Florida | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | Recruiting |
| Florida Cancer Specialists & Research Institute | West Palm Beach | Florida | Recruiting |
| Northeast Georgia Medical Center Gainesville | Gainesville | Georgia | Recruiting |
| Parkview Research Center | Fort Wayne | Indiana | Recruiting |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| Trials365, Llc | Shreveport | Louisiana | Recruiting |
| Greater Baltimore Medical Center | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Umass Memorial Medical Center, Inc. | Worcester | Massachusetts | Recruiting |
| University of Michigan Health System | Ann Arbor | Michigan | Recruiting |
| Minnesota Oncology-Minneapolis | Minneapolis | Minnesota | Recruiting |
| University of Mississippi Medical Center | Jackson | Mississippi | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| St. Vincent Regional Hospital - West End Clinic | Billings | Montana | Recruiting |
| Nebraska Methodist Hospital | Omaha | Nebraska | Recruiting |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Laura and Isaac Perlmutter Cancer Center | New York | New York | Recruiting |
| State University of New York Upstate Medical Unive | Syracuse | New York | Recruiting |
| Oncology Hematology Care, Inc | Cincinnati | Ohio | Recruiting |
| The Mark H Zangmeister Cancer Center Ohio | Columbus | Ohio | Recruiting |
| The Ohio State University Wexner Medical Center Division of Gynecologic Oncology | Hilliard | Ohio | Recruiting |
| Penn State College of Medicine | Hershey | Pennsylvania | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Texas Oncology-Austin Center | Austin | Texas | Recruiting |
| Texas Oncology-San Antonio Medical Center Pharmacy | San Antonio | Texas | Recruiting |
| Texas Oncology-Tyler | Tyler | Texas | Recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | Recruiting |
| Carilion Clinic | Roanoke | Virginia | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Blacktown Cancer & Haematology Centre-Blacktown Hospital | Blacktown | New South Wales | Recruiting |
| Concord General Repatriation Hospital | Concord | New South Wales | Recruiting |
+ 34 more sites — see the full list on the official registry below.
More Incyte Corporation trials in Spain
Other trials for the same condition
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 NCT07023627 on ClinicalTrials.gov ↗ ← All trials in Spain