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

RecruitingPhase 2

Sponsor: Incyte Corporation

Conditions: Ovarian Cancer

Interventions: INCB123667

Countries: United States, Australia, Belgium, Japan, Puerto Rico, Spain, Switzerland, United Kingdom

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (74)

Mobile, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
West Palm Beach, Florida, United States
Gainesville, Georgia, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Hilliard, Ohio, United States
Hershey, Pennsylvania, United States
Charleston, South Carolina, United States
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