Selinexor in Advanced Liposarcoma

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dedifferentiated Liposarcoma

In brief

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).

Key facts

Study ID

NCT02606461

Run by

Karyopharm Therapeutics Inc

People needed

342

Starts

2016-01-04

Expected to finish

2021-10-26

Last updated by the study team

2023-01-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado-Denver — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Northwell Health Physicians Partners — New York, New York, United States
• Duke Institute of Cancer — Durham, North Carolina, United States
• James Cancer Center, Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Vanderbilt — Nashville, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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