Selinexor in Advanced Liposarcoma

Status: Active

Description

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 total patients will be randomized to study treatment (selinexor or placebo).

Eligibility Criteria

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 two (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 less than or equal to Grade 1

Exclusion Criteria

  • Patients with pure 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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: In review
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Contact: Andrew Jay Wagner
Phone: 866-790-4500
Email: awagner@partners.org
Dana-Farber Cancer Institute
Status: Active
Contact: Melissa Beth Hohos
Phone: 617-582-7162
Email: mhohos@partners.org
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Gary K. Schwartz
Phone: 212-305-2055
Email: gks2123@cumc.columbia.edu

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Richard F. Riedel
Phone: 919-681-1883
Email: richard.riedel@duke.edu

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Melissa Amber (Moidel) Burgess
Phone: 412-647-8073
Email: burgessma@upmc.edu

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio. In the Phase 3 portion of the study, approximately 222 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio. Patients who progress during the blinded portion of the study will be unblinded and if receiving: - placebo, may cross over to open-label selinexor (60mg twice weekly) - selinexor, will be withdrawn from further treatment and followed for survival Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability. Treatment will continue until one or more of the following occurs: - Disease progression, as defined by RECIST v1.1 Response Criteria - Clinical progression, as determined by the treating physician - Unacceptable AEs or failure to tolerate study treatment - Patient withdrawal - Patient discontinuation due to non-compliance

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
Karyopharm Therapeutics Inc

Trial IDs

Primary ID KCP-330-020
Secondary IDs NCI-2016-00746, 2015-003594-14
Clinicaltrials.gov ID NCT02606461