A Phase 2 Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Other Female Genital, Ovary,
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Age: Between 18 Year(s) - 99 Year(s)
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Gender: Female
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Other Inclusion Criteria:
In order to participate in this study the following conditions must be met:- Female participants aged 18 years or older at the time of signing the ICF
- Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Have platinum-resistant disease: a. Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen, had a response (CR or PR) or had nonmeasurable disease at the start of the platinum-based therapy, and then progressed between > 3 and = 6 months after the last dose of platinum. b. 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.
- CCNE overexpression noted in tumor tissue anlaysis
You may not be eligible for this study if the following are true:
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You will not be able to participate in this study if you have:
- 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 FRa but the participant has not received mirvetuximab, soravtansine due to it being unavailable.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.