A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Summary
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.
Arms & interventions
- DrugINCB123667
Oral; tablet
- DrugInvestigator's choice of chemotherapy
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Outcome measures
Primary
Progression-Free Survival (PFS) by BICR
Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Overall Survival (OS)
Defined as the time from the date of randomization until death due to any cause.
Time frame: Up to 2 years
Secondary
Objective response by BICR
Time frame: Up to 2 years
Duration of Response (DOR) by BICR
Time frame: Up to 2 years
Progression-Free Survival (PFS) by investigator
Time frame: Up to 2 years
Objective response by investigator
Time frame: Up to 2 years
DOR by investigator
Time frame: Up to 2 years
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time frame: Up to 2 years and 30 days
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Time frame: Up to 2 years
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit
Time frame: Up to 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
Time frame: Up to 2 years
Eligibility criteria
Study locations (29)
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, 99508
City of Hope Medical Center
Duarte, California, 91010
University of California, San Diego-Moores Cancer Center
La Jolla, California, 92037
Valkyrie Clinical Trials
Los Angeles, California, 90067
University of Colorado Cancer Center
Aurora, Colorado, 80045
Georgia Cancer Center
Augusta, Georgia, 30912
Carle Cancer Center
Effingham, Illinois, 62401-2006
Northshore University Health System-Evanston Hospital
Evanston, Illinois, 60201
Women'S Cancer Care
Covington, Louisiana, 70433
Maine Center For Cancer Medicine
Scarborough, Maine, 04074
Holy Cross Hospital
Silver Spring, Maryland, 20910
Mercy Hospital St. Louis - David C. Pratt Cancer Center
St Louis, Missouri, 63141
Billings Clinic
Billings, Montana, 59101
Center of Hope
Reno, Nevada, 89511
Ny Cancer and Blood Specialists
Shirley, New York, 11967
Levine Cancer Center
Charlotte, North Carolina, 28204
Novant Presbyterian Hospital
Charlotte, North Carolina, 28204
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Cleveland Clinic
Cleveland, Ohio, 44195
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213
Wellspan Gynecologic Oncology
York, Pennsylvania, 17403
Sanford Cancer Center-Sioux Falls
Sioux Falls, South Dakota, 57104-8805
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403
Texas Oncology-Abilene
Abilene, Texas, 79606
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Fred Hutchinson Cancer Center
Seattle, Washington, 98109