Selinexor in Advanced Liposarcoma
Trial ID or NCT#
NCT02606461,
Status
NOT RECRUITING
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)
Eligibility Criteria
Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Maria Ahern
650-725-6413
View on ClinicalTrials.gov
