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