Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Purpose
The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.
Condition
- Ovarian Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histological diagnosis of 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 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. - Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy. - Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option. - Should have received prior treatment with bevacizumab unless there was a contraindication for its use. - Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRĪ±, unless there is an exception for its use on medical grounds. - Measurable disease per RECIST v1.1.
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, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy. - Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment. - Known active CNS metastases and/or carcinomatous meningitis. - Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment. - Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group A (TGA) |
INCB123667 at the protocol-defined dose. |
|
|
Experimental Treatment Group B (TGB) |
Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol. |
|
Recruiting Locations
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
Los Angeles 5368361, California 5332921 90067
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation