Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Sponsor: Incyte Corporation
ClinicalTrials ID:NCT07214779
This study assesses INCB123667 against chemotherapy in patients with platinum-resistant ovarian cancer overexpressing cyclin E1. Eligible participants must have high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, with specific prior treatment histories. Interventions include oral INCB123667 or investigator-selected chemotherapy, following protocol guidelines.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
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Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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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.
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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.
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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.
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Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
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Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
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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.
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