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.
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.
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.
Parallel
INCB123667
DrugOral; tablet
Investigator's choice of chemotherapy
DrugThe investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Progression-Free Survival (PFS) by BICR
Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
Overall Survival (OS)
Defined as the time from the date of randomization until death due to any cause.
Objective response by BICR
Defined as having a best overall response of complete response (CR) or partial response (PR), as determined by BICR per RECIST v1.1.
Duration of Response (DOR) by BICR
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Progression-Free Survival (PFS) by investigator
Defined as the time from the date of randomization until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Objective response by investigator
Defined as having a best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.
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