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
Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140
Miami Beach 4164143, Florida 4155751 33140
Trials365, Llc
Shreveport 4341513, Louisiana 4331987 71103
Shreveport 4341513, Louisiana 4331987 71103
Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204
Baltimore 4347778, Maryland 4361885 21204
Methodist Hospital Methodist Estabrook Cancer Center
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
The Mark H Zangmeister Cancer Center Ohio
Columbus 4509177, Ohio 5165418 43219
Columbus 4509177, Ohio 5165418 43219
Panoncology Trials
San Juan 4568127, PR, Puerto Rico 00935
San Juan 4568127, PR, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation