Last updated on March 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 334 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 277 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  • selinexor, will be withdrawn from further treatment and followed for survival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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Dana Farber Cancer Institute

Boston, MA United States
4.51miles
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Massachusetts General Hospital

Boston, MA United States
6.05miles
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