Selinexor in Advanced Liposarcoma

Not Recruiting

Trial ID: NCT02606461,


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).

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)

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


Inclusion Criteria:

   1. Patients ≥12 years of age

   2. Body surface area (BSA) ≥ 1.2 m2

   3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of
   DDLS requiring treatment

   4. Must have measurable disease per RECIST v1.1 Response Criteria

   5. Radiologic evidence of disease progression within 6 months prior to randomization. If
   the patient received other intervening therapy after documented disease progression,
   further disease progression must be documented after the completion of the intervening

   6. Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to
   exceed 5 prior lines)

   7. If patient received any previous systemic therapy, the last dose must have been ≥ 21
   days prior to randomization (or ≥ 5 half-lives of that drug, whichever is shorter)
   with all clinically significant therapy-related toxicities having resolved to ≤ Grade

Exclusion Criteria:

   1. Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or
   pleomorphic tumor histologic subtypes

   2. Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus
   (HIV) infection

   3. Known central nervous system metastases


drug: Selinexor

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern

New Trial Alerts