A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Purpose
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Condition
- Ovarian Cancer
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
|
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. |
|
Recruiting Locations
University of California, Los Angeles Medical Center
Los Angeles, California 90024-6995
Los Angeles, California 90024-6995
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California 92103
San Diego, California 92103
Florida Cancer Specialists & Research Institute
Fort Myers, Florida 33901
Fort Myers, Florida 33901
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
Miami Beach, Florida 33140
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Northeast Georgia Medical Center Gainesville
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Parkview Research Center
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
Norton Cancer Institute
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Trials365, Llc
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Greater Baltimore Medical Center
Baltimore, Maryland 21204
Baltimore, Maryland 21204
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Minnesota Oncology-Minneapolis
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
Washington University
St Louis, Missouri 63110
St Louis, Missouri 63110
St. Vincent Regional Hospital - West End Clinic
Billings, Montana 59106
Billings, Montana 59106
Nebraska Methodist Hospital
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
New York, New York 10016
Oncology Hematology Care, Inc
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
The Mark H Zangmeister Cancer Center Ohio
Columbus, Ohio 43219
Columbus, Ohio 43219
Texas Oncology-Austin Center
Austin, Texas 78731
Austin, Texas 78731
Cancer Care Center of South Texas-Medical Center
San Antonio, Texas 78229
San Antonio, Texas 78229
Texas Oncology-Tyler
Tyler, Texas 75702
Tyler, Texas 75702
Virginia Cancer Specialists, Pc
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Carilion Clinic
Roanoke, Virginia 24016-4962
Roanoke, Virginia 24016-4962
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Panoncology Trials
San Juan, PR, Puerto Rico 00935
San Juan, PR, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation