Selinexor in Advanced Liposarcoma
Trial ID or NCT#
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 334 total patients will be randomized to study treatment (selinexor or placebo).
A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
- 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 two (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 less than or equal to Grade 1
- 1. Patients with pure 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
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