Last updated on January 2020

Selinexor in Advanced Liposarcoma


Brief description of study

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 total patients will be randomized to study treatment (selinexor or placebo).

Detailed Study Description

In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.

In the Phase 3 portion of the study, approximately 222 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.

Patients who progress during the blinded portion of the study will be unblinded and if

receiving
  • placebo, may cross over to open-label selinexor (60mg twice weekly)
  • selinexor, will be withdrawn from further treatment and followed for survival

Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.

Treatment will continue until one or more of the following occurs:

  • Disease progression, as defined by RECIST v1.1 Response Criteria
  • Clinical progression, as determined by the treating physician
  • Unacceptable AEs or failure to tolerate study treatment
  • Patient withdrawal
  • Patient discontinuation due to non-compliance

Clinical Study Identifier: NCT02606461

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Vanderbilt

Nashville, TN United States
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Oregon Health and Science

Portland, OR United States
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Duke Institute of Cancer

Durham, NC United States
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Fox Chase Cancer Center

Philadelphia, PA United States
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University of Pennsylvania

Philadelphia, PA United States
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Mayo Clinic

Jacksonville, FL United States
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Johns Hopkins

Baltimore, MD United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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University of Michigan

Ann Arbor, MI United States
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Sarcoma Oncology Center

Santa Monica, CA United States
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MD Anderson

Houston, TX United States
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Stanford University

Stanford, CA United States
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Yale Cancer Center

New Haven, CT United States
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Mayo Clinic Rochester

Rochester, MN United States
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UZ Brussel

Brussels, Belgium
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UCL Saint-Luc

Brussels, Belgium
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UZ Gent

Ghent, Belgium
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McGill University

Montréal, QC Canada
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Oscar Lambret Center

Lille Cedex 307, France
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Timone University Hospital

Marseille Cedex 5, France
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The Christie

Manchester, United Kingdom
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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McGill University

Montréal, QC Canada
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