A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

Incyte Corporation

Summary

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Eligibility

Age range: 18–99 years
Sex: Female
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Histological diagnosis of a 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 a 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. * Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is ac…

Interventions

Drug
INCB123667
Administered orally twice daily (BID).

Locations (82)

Usa Health Mitchell Cancer Institute
Mobile, Alabama
Uams Winthrop P Rockefeller Cancer Institute
Little Rock, Arkansas
University of California, Los Angeles Medical Center
Los Angeles, California
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California
Medstar Georgetown University Hospital
Washington D.C., District of Columbia
Florida Cancer Specialists & Research Institute
Fort Myers, Florida