A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

Who is this study for? Patients diagnosed with advanced unresectable dedifferentiated liposarcoma
What treatments are being studied? Selinexor
Status: Active, not recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: No
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
University of California, Los Angeles
Los Angeles
Sarcoma Oncology Center
Santa Monica
Stanford University
Stanford
Colorado
University of Colorado-Denver
Denver
Connecticut
Yale Cancer Center
New Haven
Florida
Mayo Clinic
Jacksonville
Illinois
Northwestern Memorial Hospital
Chicago
Massachusetts
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Maryland
Johns Hopkins
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic Rochester
Rochester
Missouri
Washington University School of Medicine
Saint Louis
North Carolina
Duke Institute of Cancer
Durham
New York
Columbia University Medical Center
New York
Memorial Sloan Kettering Cancer Center
New York
Northwell Health Physicians Partners
New York
Ohio
James Cancer Center, Ohio State University
Columbus
Oregon
Oregon Health and Science
Portland
Pennsylvania
Fox Chase Cancer Center
Philadelphia
University of Pennsylvania
Philadelphia
University of Pittsburgh Medical Center (UPMC)
Pittsburgh
Tennessee
Vanderbilt
Nashville
Texas
MD Anderson
Houston
Washington
Fred Hutchinson Cancer Research Center
Seattle
Other Locations
Belgium
UCL Saint-Luc
Brussels
UZ Brussel
Brussels
UZ Gent
Ghent
Canada
Cross Cancer Center - Alberta Health Services
Edmonton
McGill University
Montréal
The Ottawa Hospital Cancer
Ottawa
Princess Margaret Hospital
Toronto
France
Institut Bergonie
Bordeaux,
Oscar Lambret Center
Lille Cedex 307
Centre Leon Berard
Lyon Cedex
Timone University Hospital
Marseille Cedex 5
Institut Régional du Cancer de Montpellier (ICM)
Montpellier
CLCC Antoine Lacassagne
Nice
Institut Curie
Paris
Institut Claudius Regaud
Toulouse
Institut Gustave Roussy
Villejuif
Germany
Helios Hospital Berlin-Buch
Berlin
Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I
Dresden
National Center for Tumor Diseases, Univeristy Hospital Heidelberg
Heidelberg
University Hospital Mannheim
Mannheim
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen
Muenchen
Israel
Soroka University Medical Center
Be'er Sheva
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petach Tikva
Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical
Tel Aviv
Assaf Harofe Medical Center
Zerifin
Italy
Candiolo Cancer Institute
Candiolo
Istituto Nazionale dei Tumori, Milan
Milano
U.O.C. Oncologia Medica Oncology Department
Palermo
Policlinico Universitario Campus Biomedico
Roma
Spain
Germans Trias Pujol University Hospital
Badalona
Hospital ICO Bellvitge
Barcelona
Hospital Sant Pau Barcelona
Barcelona
Vall d´hebron University Hospital
Barcelona
Hospital Universitario Clínico San Carlos
Madrid
Hospital Universitario Virgen Del Rocio
Sevilla
Hospital La Fe Valencia
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
Göteborg
Skane University Hospital
Lund
Onkologiska Kliniken
Stockholm
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge
The Royal Marsden NHS Foundation Trust
London
University College London Hospitals
London
The Christie
Manchester
Time Frame
Start Date: January 4, 2016
Estimated Completion Date: December 2021
Participants
Target number of participants: 342
Treatments
Experimental: Phase 2 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until progressive disease (PD).
Experimental: Phase 3 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 38 months until PD.
Placebo Comparator: Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor
Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.
Placebo Comparator: Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor
Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 14 months until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.
Sponsors
Leads: Karyopharm Therapeutics Inc

This content was sourced from clinicaltrials.gov

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