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: 05 Dec 2017

At a glance

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

    • 29 Nov 2017 Planned End Date changed from 1 Jul 2019 to 1 Mar 2020.
    • 29 Nov 2017 Planned primary completion date changed from 1 Jul 2018 to 1 Nov 2019.
    • 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.
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