This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Arizona Oncology
Tucson, Arizona, United States
Stanford University
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists (Sarah Cannon Research Institute)
West Palm Beach, Florida, United States
Gynecological Cancer Institute of Chicago
Oak Lawn, Illinois, United States
Progression Free Survival (PFS)
Compare progression free survival of the two treatment arms as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1
Time from randomization until documented PD or death due to any cause, whichever occurs first. Documented PD will be based on BICR assessments.
Time frame: Time from randomization until PD or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Disease Specific Survival (DSS)
Time from randomization until date of death from endometrial cancer.
Time frame: Time from randomization until death from endometrial cancer (approximately 12 months after the last participant enrolled)
Overall Survival (OS)
Time from randomization until date of death from any cause.
Time frame: Time from randomization until death (approximately 12 months after the last participant enrolled)
Time to First Subsequent Treatment (TFST)
Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first.
Time frame: Time from randomization until first therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Progression-free Survival After Subsequent Treatment (PFS2)
Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy.
Time frame: Time from randomization until second documented PD or death (approximately 12 months after the last participant enrolled)
Time to Second Subsequent Treatment (TSST)
Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first.
Time frame: Time from randomization until second therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Disease Control Rate (DCR)
Best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among patients with PR as best response to prior chemotherapy.
Time frame: Time from randomization up to approximately 16 weeks
Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Patient-reported outcomes will be measured by the EORTC QLQ C30 questionnaire.
Time frame: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Health-Related Quality of Life: Measured by EORTC QLQ-EN24
Patient-reported outcomes will be measured by the EORTC QLQ-EN24 questionnaire.
Time frame: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Patient-reported outcomes will be measured by the EORTC EQ-5D-5L.
Time frame: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs
Time frame: From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)
Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results
Time frame: From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)
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Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)
Kansas City, Missouri, United States
NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 68 more locations