Genitourinary & Gynecologic Cancer
A study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Incyte Study ID:
INCB123667-203
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
GOG Foundation
Study Contact Information:
Clinical Study Purpose
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
GOG Foundation
DATE
Aug 2025 - Apr 2027
TYPE
Interventional
PHASE
Phase 2
SEX
Female only
AGE
18 - 99 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
No locations found.
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Have platinum-resistant disease:
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: 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.
Protocol Summary
Incyte Study ID:
INCB123667-203
Primary Purpose:
Treatment
Allocation:
Non-randomized
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
160
Primary Outcome
Open
Objective Response by IRC
Timeframe: Up to 2 years
Secondary Outcome
Open
Duration of Response (DOR) by IRC
Timeframe: Up to 2 years
Progression-Free Survival (PFS) by IRC
Timeframe: Up to 2 years
Overall Survival (OS)
Timeframe: Up to 2 years
Objective Response by Investigator
Timeframe: Up to 2 years
DOR by investigator
Timeframe: Up to 2 years
PFS by Investigator
Timeframe: Up to 2 years
Treatment Emergent Adverse Events (TEAE'S)
Timeframe: Up to 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Timeframe: Up to 2 years and 30 days