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Selinexor in Advanced Liposarcoma
Not Recruiting
Trial ID: NCT02606461,
Purpose
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
Professor of Medicine (Oncology)
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
Intervention(s):
drug: Selinexor
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Ahern
650-725-6413