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

Trial Profile

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

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Sep 2017

At a glance

  • Drugs Selinexor (Primary)
  • Indications Liposarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms SEAL
  • Sponsors Karyopharm Therapeutics
  • Most Recent Events

    • 20 Sep 2017 According to a Karyopharm Therapeutics media release, FDA has confirmed their acceptance of the proposed Phase 3 SEAL study design, including the PFS primary endpoint, and agreed that positive results from this study could support regulatory approval in the patient with advanced dedifferentiated liposarcoma.
    • 20 Sep 2017 According to a Karyopharm Therapeutics media release, phase 3 portion was originally initiated in North America, is ongoing and has been expanded to include Europe. 222 patients are expected to be enrolled and topline data are anticipated by the end of 2019 from phase 3 portion of this trial.
    • 20 Sep 2017 Results presented in a Karyopharm Therapeutics Media Release.
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