Phase 2/3 Trial of Selinexor for Dedifferentiated Liposarcoma

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Researchers are evaluating the safety and efficacy of selinexor, an orally administered inhibitor of CRM1, among patients with unresectable dedifferentiated liposarcoma.
Researchers are evaluating the safety and efficacy of selinexor, an orally administered inhibitor of CRM1, among patients with unresectable dedifferentiated liposarcoma.

Title: A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)1

Study Director: Michael Kauffman, MD, PhD, Karyopharm Therapeutics Inc

Description: For this double-blind, multi-center, randomized phase 2/3 trial (ClinicalTrials.gov Identifier: NCT02606461), researchers are evaluating the safety and efficacy of selinexor, an orally administered inhibitor of CRM1, among patients with unresectable dedifferentiated liposarcoma.

In the phase 2 portion of this trial, an estimated 100 patients will be randomly assigned 1:1 to selinexor or placebo; in the phase 3 portion, an estimated 195 patients will be randomly assigned 2:1 to selinexor or placebo.

The primary endpoint is progression-free survival. Total estimated enrollment is 245 patients.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit  https://clinicaltrials.gov/ct2/show/NCT02606461.

Status: This study is open and recruiting patients as of July 28, 2017.

This study is sponsored by Karyopharm Therapeutics Inc.

Reference

  1. Clinicaltrials.gov. Selinexor in advanced liposarcoma (SEAL) .   NCT02606461.  https://clinicaltrials.gov/ct2/show/NCT02606461. Accessed July 28, 2017.

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