Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT03555422
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    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
  • Matching placebo for selinexor — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 5, 2018
Status verified
Apr 2026
Primary completion
Jan 22, 2022
Completion
Apr 3, 2025

Study Design

Enrollment
263 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor
    Participants will receive fixed dose of selinexor 80 mg (or 60 mg for participants with a body mass index \[BMI\] less than \[\<\] 20 kilogram per meter square \[kg/m\^2\]) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
  • Placebo Comparator: Matching placebo for selinexor
    Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Arizona OncologyTucsonArizona85711-
Stanford UniversityPalo AltoCalifornia94304-
Moffitt Cancer CenterTampaFlorida33612-
Florida Cancer Specialists (Sarah Cannon Research Institute)West Palm BeachFlorida33401-
Gynecological Cancer Institute of ChicagoOak LawnIllinois60453-
Parkview Research CenterFort WayneIndiana46845-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)Kansas CityMissouri64132-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU LangoneNew YorkNew York10016-
University of Oklahoma Health Sciences Center - Stephenson Cancer CenterOklahoma CityOklahoma73104-
Oncology Associates of OregonEugeneOregon97401-
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905-
Tennessee Oncology Nashville (Sarah Cannon Research Institute)NashvilleTennessee37203-
Texas Oncology, AustinAustinTexas78731-
Texas Oncology DFWDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-
Texas Oncology DFWFort WorthTexas76104-
VCU Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Tucson, AZ

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology· Tucson, AZStanford University· Palo Alto, CAMoffitt Cancer Center· Tampa, FLFlorida Cancer Specialists (Sarah Cannon Research Institute)· West Palm Beach, FLGynecological Cancer Institute of Chicago· Oak Lawn, ILParkview Research Center· Fort Wayne, IN

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