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Selinexor in Advanced Liposarcoma — SEAL  

Dedifferentiated Liposarcoma Clinical Trial

Official title:
A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

Clinical Trial Summary

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).

Clinical Trial 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 285 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unblinded and if receiving: - placebo, may cross over to open-label selinexor (60mg twice-weekly) - selinexor, will be withdrawn from further treatment and followed for survival Study treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle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 adverse events (AEs) or failure to tolerate study treatment - Patient withdrawal - Patient discontinuation due to non-compliance ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02606461
Study type Interventional
Source Karyopharm Therapeutics Inc
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 4, 2016
Completion date October 26, 2021
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