A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorIncyte Corporation

About this trial

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

Eligibility criteria

Qualifiers

Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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 acceptable as long as the sample is no older than 5 years.

Disqualifiers

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 FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.

Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.

Trial design

Treatments tested in this trial

  • INCB123667

Treatment groups

160 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Incyte Corporation

Lead sponsor

ENGOT Foundation

Collaborator

GOG Foundation

Collaborator