Selinexor in Advanced Liposarcoma (SEAL)

• ClinicalTrials.gov Identifier: NCT02606461
• Recruitment Status: Completed
• First Posted: November 17, 2015
• Results First Posted: December 7, 2021
• Last Update Posted: January 23, 2023
• Sponsor: Karyopharm Therapeutics Inc
• Information provided by (Responsible Party): Karyopharm Therapeutics Inc

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Dedifferentiated Liposarcoma	Drug: Selinexor; Drug: Placebo	Phase 2; Phase 3

Detailed 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• selinexor, will be withdrawn from further treatment and followed for survival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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 342 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: January 4, 2016
• Actual Primary Completion Date: October 28, 2020
• Actual Study Completion Date: October 26, 2021

Arms and Interventions

Arm	Intervention/treatment
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 (42-day) cycle until progressive disease (PD).	Drug: Selinexor; Selinexor 60mg; Other Name: KPT-330
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 (42-day) cycle until PD.	Drug: Selinexor; Selinexor 60mg; Other Name: KPT-330
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 (42-day) cycle 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.	Drug: Placebo; Other Name: sugar pill
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 (42-day) cycle 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.	Drug: Placebo; Other Name: sugar pill

Outcome Measures

Primary Outcome Measures :

1. Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) ]
   PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions.
2. Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 [ Time Frame: From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) ]
   PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
3. Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 [ Time Frame: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) ]
   PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
4. Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 [ Time Frame: From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) ]
   PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Secondary Outcome Measures :

1. Phase 3 Double Blind: Overall Survival (OS) [ Time Frame: From date of randomization until death due to any cause, whichever occurred first (up to 70 months) ]
   OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.
2. Phase 3 Open Label: Overall Survival (OS) [ Time Frame: From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months) ]
   OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.
3. Phase 2 Double Blind: Overall Survival (OS) [ Time Frame: From the date of randomization until death due to any cause, whichever occurred first (up to 70 months) ]
   OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.
4. Phase 2 Open Label: Overall Survival (OS) [ Time Frame: From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months) ]
   OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.
5. Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 [ Time Frame: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) ]
   TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
6. Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 [ Time Frame: From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) ]
   TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
7. Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 [ Time Frame: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) ]
   TTP was defined as the time from date of randomization until ICR-determined PD as per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
8. Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 [ Time Frame: From date of randomization in the Phase 2 open-label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) ]
   TTP was defined as the time from date of randomization in the Phase 2 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
9. Phase 3 Double Blind: Overall Response Rate (ORR) [ Time Frame: From date of randomization until the documentation of CR or PR (up to 70 months) ]
   ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR), per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
10. Phase 3 Open Label: Overall Response Rate (ORR) [ Time Frame: From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months) ]
    ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
11. Phase 2 Double Blind: Overall Response Rate (ORR) [ Time Frame: From date of randomization until the documentation of CR or PR (up to 70 months) ]
    ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
12. Phase 2 Open Label: Overall Response Rate (ORR) [ Time Frame: From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months) ]
    ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
13. Phase 3 Double Blind: Duration of Response (DOR) [ Time Frame: From first occurrence of CR or PR until the first date of PD (up to 70 months) ]
    DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
14. Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment [ Time Frame: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 70 months) ]
    PFS was defined as the time from date of randomization until the first date of PD, per RECIST version 1.1, or death due to any cause as defined by the Investigator based on clinical and/or radiologic criteria. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
15. Phase 3 Double Blind: Time to Next Treatment (TTNT) [ Time Frame: Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months) ]
    TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
16. Phase 2 Double Blind: Time to Next Treatment (TTNT) [ Time Frame: Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months) ]
    TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
17. Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From start of study drug administration up to 70 months ]
    An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE was defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
18. Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs [ Time Frame: From start of study drug administration up to 70 months ]
    An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
19. Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs [ Time Frame: From start of study drug administration up to 70 months ]
    An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
20. Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs [ Time Frame: From start of study drug administration up to 70 months ]
    An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
21. Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30) [ Time Frame: Baseline up to Day 1387 ]
    The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).
22. Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30) [ Time Frame: Baseline up to Day 379 ]
    The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

University of California, Los Angeles

Los Angeles, California, United States, 90095

Sarcoma Oncology Center

Santa Monica, California, United States, 90403

Stanford University

Stanford, California, United States, 94305

United States, Colorado

University of Colorado-Denver

Denver, Colorado, United States, 80202

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520-8032

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

United States, Maryland

Johns Hopkins

Baltimore, Maryland, United States, 21231

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Northwell Health Physicians Partners

New York, New York, United States, 11042

United States, North Carolina

Duke Institute of Cancer

Durham, North Carolina, United States, 27710

United States, Ohio

James Cancer Center, Ohio State University

Columbus, Ohio, United States, 43210-1240

United States, Oregon

Oregon Health and Science

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19106

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States, 15232

United States, Tennessee

Vanderbilt

Nashville, Tennessee, United States, 37232

United States, Texas

MD Anderson

Houston, Texas, United States, 77030

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Belgium

UZ Brussel

Brussels, Belgium, 1090

UCL Saint-Luc

Brussels, Belgium, 1200

UZ Gent

Ghent, Belgium, 9000

Canada, Alberta

Cross Cancer Center - Alberta Health Services

Edmonton, Alberta, Canada, T6G1Z2

Canada, Ontario

The Ottawa Hospital Cancer

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

McGill University

Montréal, Quebec, Canada, H4A3J1

France

Institut Bergonie

Bordeaux,, France, 33076

Oscar Lambret Center

Lille Cedex 307, France, 59020

Centre Leon Berard

Lyon Cedex, France, 96373

Timone University Hospital

Marseille Cedex 5, France, 13385

Institut Régional du Cancer de Montpellier (ICM)

Montpellier, France, 34298

CLCC Antoine Lacassagne

Nice, France, 06789

Institut Curie

Paris, France, 75248

Institut Claudius Regaud

Toulouse, France, 31059

Institut Gustave Roussy

Villejuif, France, 94110

Germany

Helios Hospital Berlin-Buch

Berlin, Germany, 13125

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

Dresden, Germany, 01307

National Center for Tumor Diseases, Univeristy Hospital Heidelberg

Heidelberg, Germany, 69120

University Hospital Mannheim

Mannheim, Germany, 68167

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

Muenchen, Germany, 81675

Israel

Soroka University Medical Center

Be'er Sheva, Israel, 84101

Hadassah Medical Center

Jerusalem, Israel, 91120

Rabin Medical Center

Petach Tikva, Israel, 4941492

Sheba Medical Center

Ramat Gan, Israel, 52621

Tel Aviv Sourasky Medical

Tel Aviv, Israel, 64239

Assaf Harofe Medical Center

Zerifin, Israel, 7030000

Italy

Candiolo Cancer Institute

Candiolo, Italy, 10060

Istituto Nazionale dei Tumori, Milan

Milano, Italy, 20133

U.O.C. Oncologia Medica Oncology Department

Palermo, Italy, 90127

Policlinico Universitario Campus Biomedico

Roma, Italy, 00128

Spain

"Germans Trias Pujol" University Hospital

Badalona, Spain, 41013

Vall d´hebron University Hospital

Barcelona, Spain, 08035

Hospital Sant Pau Barcelona

Barcelona, Spain, 08041

Hospital ICO Bellvitge

Barcelona, Spain, 08908

Hospital Universitario Clínico San Carlos

Madrid, Spain, 28040

Hospital Universitario Virgen Del Rocio

Sevilla, Spain, 41013

Hospital La Fe Valencia

Valencia, Spain, 46026

Sweden

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Skane University Hospital

Lund, Sweden, 221 85

Onkologiska Kliniken

Stockholm, Sweden, 171 76

United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

University College London Hospitals

London, United Kingdom, NW1 2BU

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

The Christie

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Karyopharm Therapeutics Inc

  Study Documents (Full-Text)

Documents provided by Karyopharm Therapeutics Inc:

Study Protocol  [PDF] May 21, 2020

Statistical Analysis Plan  [PDF] September 20, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.

• Responsible Party: Karyopharm Therapeutics Inc
• ClinicalTrials.gov Identifier: NCT02606461
• Other Study ID Numbers: KCP-330-020; 2015-003594-14 ( EudraCT Number )
• First Posted: November 17, 2015
• Results First Posted: December 7, 2021
• Last Update Posted: January 23, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karyopharm Therapeutics Inc:

Advanced unresectable dedifferentiated liposarcoma; selinexor; KCP-330; Karyopharm; Phase 2 / 3; dedifferentiated liposarcoma; Liposarcoma

Additional relevant MeSH terms:

Liposarcoma; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma