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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
  • Drug: INCB123667
    Administered orally twice daily (BID).
Experimental
Cohort 2 		INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
  • Drug: INCB123667
    Administered orally twice daily (BID).
Experimental
Cohort 3 		INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
  • Drug: INCB123667
    Administered orally twice daily (BID).

Recruiting Locations

Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140

Trials365, Llc
Shreveport 4341513, Louisiana 4331987 71103

Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204

Methodist Hospital Methodist Estabrook Cancer Center
Omaha 5074472, Nebraska 5073708 68114

Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016

The Mark H Zangmeister Cancer Center Ohio
Columbus 4509177, Ohio 5165418 43219

Panoncology Trials
San Juan 4568127, PR, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.