Selinexor in Advanced Liposarcoma

Last updated: January 5, 2023
Sponsor: Karyopharm Therapeutics Inc
Overall Status: Completed

Phase

2/3

Condition

Sarcoma (Pediatric)

Infantile Fibrosarcoma

Soft Tissue Sarcoma

Treatment

N/A

Clinical Study ID

NCT02606461
KCP-330-020
2015-003594-14
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

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 ofDDLS 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. Ifthe patient received other intervening therapy after documented disease progression,further disease progression must be documented after the completion of the interveningtherapy
  6. Must have had at least 2 prior lines of systemic therapy for liposarcoma (not toexceed 5 prior lines)
  7. If patient received any previous systemic therapy, the last dose must have been ≥ 21days 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

Exclusion Criteria:

  1. Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell orpleomorphic tumor histologic subtypes
  2. Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection
  3. Known central nervous system metastases

Study Design

Total Participants: 342
Study Start date:
January 04, 2016
Estimated Completion Date:
October 26, 2021

Study Description

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 285 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  • selinexor, will be withdrawn from further treatment and followed for survival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 adverse events (AEs) or failure to tolerate study treatment

  • Patient withdrawal

  • Patient discontinuation due to non-compliance

Connect with a study center

  • UCL Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • UZ Gent

    Ghent, 9000
    Belgium

    Site Not Available

  • Cross Cancer Center - Alberta Health Services

    Edmonton, Alberta T6G1Z2
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer

    Ottawa, Ontario
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • McGill University

    Montréal, Quebec H4A3J1
    Canada

    Site Not Available

  • Institut Bergonie

    Bordeaux,, 33076
    France

    Site Not Available

  • Oscar Lambret Center

    Lille Cedex 307, 59020
    France

    Site Not Available

  • Centre Leon Berard

    Lyon Cedex, 96373
    France

    Site Not Available

  • Timone University Hospital

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • Institut Régional du Cancer de Montpellier (ICM)

    Montpellier, 34298
    France

    Site Not Available

  • CLCC Antoine Lacassagne

    Nice, 06789
    France

    Site Not Available

  • Institut Curie

    Paris, 75248
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94110
    France

    Site Not Available

  • Helios Hospital Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I

    Dresden, 01307
    Germany

    Site Not Available

  • Sarkomzentrum Universitaeres Cancer Center Hamburg (UCCH)

    Hamburg, 20246
    Germany

    Site Not Available

  • National Center for Tumor Diseases, Univeristy Hospital Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • University Hospital Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen

    Muenchen, 81675
    Germany

    Site Not Available

  • University Hospital Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Soroka University Medical Center

    Be'er Sheva, 84101
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Assaf Harofe Medical Center

    Zerifin, 7030000
    Israel

    Site Not Available

  • Candiolo Cancer Institute

    Candiolo, 10060
    Italy

    Site Not Available

  • Istituto Nazionale dei Tumori, Milan

    Milano, 20133
    Italy

    Site Not Available

  • U.O.C. Oncologia Medica Oncology Department

    Palermo, 90127
    Italy

    Site Not Available

  • Policlinico Universitario Campus Biomedico

    Roma, 00128
    Italy

    Site Not Available

  • "Germans Trias Pujol" University Hospital

    Badalona, 41013
    Spain

    Site Not Available

  • Hospital ICO Bellvitge

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Sant Pau Barcelona

    Barcelona, 08041
    Spain

    Site Not Available

  • Vall d´hebron University Hospital

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital La Fe Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Göteborg, 413 45
    Sweden

    Site Not Available

  • Skane University Hospital

    Lund, 221 85
    Sweden

    Site Not Available

  • Onkologiska Kliniken

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • The Christie

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado-Denver

    Denver, Colorado 80202
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520-8032
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Northwell Health Physicians Partners

    New York, New York 11042
    United States

    Site Not Available

  • Columbia University Medical Center

    New York City, New York 10032
    United States

    Site Not Available

  • Duke Institute of Cancer

    Durham, North Carolina 27710
    United States

    Site Not Available

  • James Cancer Center, Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Oregon Health and Science

    Portland, Oregon 97239
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Vanderbilt

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

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