Selinexor in Advanced Liposarcoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02606461
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Dedifferentiated Liposarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor 60mg
  • Placebo — DRUG

Study Details

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

Key Dates

Start date
Jan 4, 2016
Status verified
Jan 2023
Primary completion
Oct 28, 2020
Completion
Oct 26, 2021

Study Design

Enrollment
342 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2 Double-blinded: Selinexor
    Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until progressive disease (PD).
  • Experimental: Phase 3 Double-blinded: Selinexor
    Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD.
  • Placebo Comparator: Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor
    Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.
  • Placebo Comparator: Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor
    Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.

Primary Outcome Measure

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) ]

Locations (26)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California, Los AngelesLos AngelesCalifornia90095-
Sarcoma Oncology CenterSanta MonicaCalifornia90403-
Stanford UniversityStanfordCalifornia94305-
University of Colorado-DenverDenverColorado80202-
Yale Cancer CenterNew HavenConnecticut06520-8032-
Mayo ClinicJacksonvilleFlorida32224-
Northwestern Memorial HospitalChicagoIllinois60611-
Johns HopkinsBaltimoreMaryland21231-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Northwell Health Physicians PartnersNew YorkNew York11042-
Duke Institute of CancerDurhamNorth Carolina27710-
James Cancer Center, Ohio State UniversityColumbusOhio43210-1240-
Oregon Health and SciencePortlandOregon97239-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of PennsylvaniaPhiladelphiaPennsylvania19106-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15232-
VanderbiltNashvilleTennessee37232-
MD AndersonHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California, Los Angeles· Los Angeles, CASarcoma Oncology Center· Santa Monica, CAStanford University· Stanford, CAUniversity of Colorado-Denver· Denver, COYale Cancer Center· New Haven, CT

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