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)

Status Completed

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• selinexor, will be withdrawn from further treatment and followed for survival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 ;

Related Conditions & MeSH terms

• Dedifferentiated Liposarcoma
• Liposarcoma

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