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Selinexor in Advanced Liposarcoma
Trial Status: complete
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).
Inclusion Criteria
Patients ≥12 years of age
Body surface area (BSA) ≥ 1.2 m2
Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
Must have measurable disease per RECIST v1.1 Response Criteria
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
Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
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
Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or pleomorphic tumor histologic subtypes
Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection
Known central nervous system metastases
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02606461.
