Education and Training

Selinexor in Advanced Liposarcoma

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).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Selinexor
  • drug: Placebo

Eligibility


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
   therapy

   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
   1

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

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern
650-725-6413
Not Recruiting