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Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

RECRUITING
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18 years and over
This study is NOT accepting healthy volunteers
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.

DRUG: INCB123667, DRUG: Investigator's choice of chemotherapy

Ovarian Cancer

INCB123667

Incyte Corporation Call Center (US) - medinfo@incyte.com
NCT07214779

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