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Selinexor in Advanced Liposarcoma (SEAL)

Primary Purpose

Dedifferentiated Liposarcoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Selinexor

Placebo

About this trial

This is an interventional treatment trial for Dedifferentiated Liposarcoma focused on measuring Advanced unresectable dedifferentiated liposarcoma, selinexor, KCP-330, Karyopharm, Phase 2 / 3, dedifferentiated liposarcoma, Liposarcoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

Cedars-Sinai Medical Center
University of California, Los Angeles
Sarcoma Oncology Center
Stanford University
University of Colorado-Denver
Yale Cancer Center
Mayo Clinic
Northwestern Memorial Hospital
Johns Hopkins
Massachusetts General Hospital
Dana Farber Cancer Institute
University of Michigan
Mayo Clinic Rochester
Washington University School of Medicine
Columbia University Medical Center
Memorial Sloan Kettering Cancer Center
Northwell Health Physicians Partners
Duke Institute of Cancer
James Cancer Center, Ohio State University
Oregon Health and Science
University of Pennsylvania
Fox Chase Cancer Center
University of Pittsburgh Medical Center (UPMC)
Vanderbilt
MD Anderson
Fred Hutchinson Cancer Research Center
UZ Brussel
UCL Saint-Luc
UZ Gent
Cross Cancer Center - Alberta Health Services
The Ottawa Hospital Cancer
Princess Margaret Hospital
McGill University
Institut Bergonie
Oscar Lambret Center
Centre Leon Berard
Timone University Hospital
Institut Régional du Cancer de Montpellier (ICM)
CLCC Antoine Lacassagne
Institut Curie
Institut Claudius Regaud
Institut Gustave Roussy
Helios Hospital Berlin-Buch
Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I
National Center for Tumor Diseases, Univeristy Hospital Heidelberg
University Hospital Mannheim
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen
Soroka University Medical Center
Hadassah Medical Center
Rabin Medical Center
Sheba Medical Center
Tel Aviv Sourasky Medical
Assaf Harofe Medical Center
Candiolo Cancer Institute
Istituto Nazionale dei Tumori, Milan
U.O.C. Oncologia Medica Oncology Department
Policlinico Universitario Campus Biomedico
"Germans Trias Pujol" University Hospital
Vall d´hebron University Hospital
Hospital Sant Pau Barcelona
Hospital ICO Bellvitge
Hospital Universitario Clínico San Carlos
Hospital Universitario Virgen Del Rocio
Hospital La Fe Valencia
Sahlgrenska Universitetssjukhuset
Skane University Hospital
Onkologiska Kliniken
Cambridge University Hospitals NHS Foundation Trust
University College London Hospitals
The Royal Marsden NHS Foundation Trust
The Christie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Phase 2 Double-blinded: Selinexor

Phase 3 Double-blinded: Selinexor

Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor

Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor

Arm Description

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).

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.

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.

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.

Outcomes

Primary Outcome Measures

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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.

Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1

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.

Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1

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.

Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1

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

Phase 3 Double Blind: Overall Survival (OS)

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.

Phase 3 Open Label: Overall Survival (OS)

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.

Phase 2 Double Blind: Overall Survival (OS)

Phase 2 Open Label: Overall Survival (OS)

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.

Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1

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.

Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1

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.

Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1

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.

Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1

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.

Phase 3 Double Blind: Overall Response Rate (ORR)

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.

Phase 3 Open Label: Overall Response Rate (ORR)

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.

Phase 2 Double Blind: Overall Response Rate (ORR)

Phase 2 Open Label: Overall Response Rate (ORR)

Phase 3 Double Blind: Duration of Response (DOR)

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.

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment

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.

Phase 3 Double Blind: Time to Next Treatment (TTNT)

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Phase 2 Double Blind: Time to Next Treatment (TTNT)

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

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.

Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs

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.

Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs

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.

Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs

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.

Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)

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).

Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)

Full Information

NCT ID

NCT02606461

First Posted

October 13, 2015

Last Updated

January 5, 2023

Sponsor

Karyopharm Therapeutics Inc

1. Study Identification

Unique Protocol Identification Number

NCT02606461

Brief Title

Selinexor in Advanced Liposarcoma

Acronym

SEAL

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 4, 2016 (Actual)

Primary Completion Date

October 28, 2020 (Actual)

Study Completion Date

October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Karyopharm Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dedifferentiated Liposarcoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 2 Double-blinded: Selinexor

Arm Type

Experimental

Arm Description

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).

Arm Title

Phase 3 Double-blinded: Selinexor

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor

Arm Type

Placebo Comparator

Arm Description

Arm Title

Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Selinexor

Other Intervention Name(s)

KPT-330

Intervention Description

Selinexor 60mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

sugar pill

Primary Outcome Measure Information:

Title

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Description

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)

Title

Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1

Description

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)

Title

Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1

Description

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)

Title

Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1

Description

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)

Secondary Outcome Measure Information:

Title

Phase 3 Double Blind: Overall Survival (OS)

Description

Time Frame

From date of randomization until death due to any cause, whichever occurred first (up to 70 months)

Title

Phase 3 Open Label: Overall Survival (OS)

Description

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)

Title

Phase 2 Double Blind: Overall Survival (OS)

Description

Time Frame

From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)

Title

Phase 2 Open Label: Overall Survival (OS)

Description

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)

Title

Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1

Description

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)

Title

Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1

Description

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)

Title

Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1

Description

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)

Title

Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1

Description

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)

Title

Phase 3 Double Blind: Overall Response Rate (ORR)

Description

Time Frame

From date of randomization until the documentation of CR or PR (up to 70 months)

Title

Phase 3 Open Label: Overall Response Rate (ORR)

Description

Time Frame

From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)

Title

Phase 2 Double Blind: Overall Response Rate (ORR)

Description

Time Frame

From date of randomization until the documentation of CR or PR (up to 70 months)

Title

Phase 2 Open Label: Overall Response Rate (ORR)

Description

Time Frame

From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)

Title

Phase 3 Double Blind: Duration of Response (DOR)

Description

Time Frame

From first occurrence of CR or PR until the first date of PD (up to 70 months)

Title

Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment

Description

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)

Title

Phase 3 Double Blind: Time to Next Treatment (TTNT)

Description

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Time Frame

Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)

Title

Phase 2 Double Blind: Time to Next Treatment (TTNT)

Description

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Time Frame

Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)

Title

Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Description

Time Frame

From start of study drug administration up to 70 months

Title

Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs

Description

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.

Time Frame

From start of study drug administration up to 70 months

Title

Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs

Description

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.

Time Frame

From start of study drug administration up to 70 months

Title

Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs

Description

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.

Time Frame

From start of study drug administration up to 70 months

Title

Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)

Description

Time Frame

Baseline up to Day 1387

Title

Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)

Description

Time Frame

Baseline up to Day 379

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Sarcoma Oncology Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Colorado-Denver

City

Denver

State/Province

Colorado

ZIP/Postal Code

80202

Country

United States

Facility Name

Yale Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8032

Country

United States

Facility Name

Mayo Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Northwell Health Physicians Partners

City

New York

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Duke Institute of Cancer

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

James Cancer Center, Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210-1240

Country

United States

Facility Name

Oregon Health and Science

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

University of Pittsburgh Medical Center (UPMC)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

MD Anderson

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

UZ Brussel

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

UCL Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Gent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Cross Cancer Center - Alberta Health Services

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G1Z2

Country

Canada

Facility Name

The Ottawa Hospital Cancer

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

McGill University

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A3J1

Country

Canada

Facility Name

Institut Bergonie

City

Bordeaux,

ZIP/Postal Code

33076

Country

France

Facility Name

Oscar Lambret Center

City

Lille Cedex 307

ZIP/Postal Code

59020

Country

France

Facility Name

Centre Leon Berard

City

Lyon Cedex

ZIP/Postal Code

96373

Country

France

Facility Name

Timone University Hospital

City

Marseille Cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Institut Régional du Cancer de Montpellier (ICM)

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

CLCC Antoine Lacassagne

City

Nice

ZIP/Postal Code

06789

Country

France

Facility Name

Institut Curie

City

Paris

ZIP/Postal Code

75248

Country

France

Facility Name

Institut Claudius Regaud

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94110

Country

France

Facility Name

Helios Hospital Berlin-Buch

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

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

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

National Center for Tumor Diseases, Univeristy Hospital Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

University Hospital Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

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

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Soroka University Medical Center

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Rabin Medical Center

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Tel Aviv Sourasky Medical

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Assaf Harofe Medical Center

City

Zerifin

ZIP/Postal Code

7030000

Country

Israel

Facility Name

Candiolo Cancer Institute

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Facility Name

Istituto Nazionale dei Tumori, Milan

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

U.O.C. Oncologia Medica Oncology Department

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Policlinico Universitario Campus Biomedico

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

"Germans Trias Pujol" University Hospital

City

Badalona

ZIP/Postal Code

41013

Country

Spain

Facility Name

Vall d´hebron University Hospital

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Sant Pau Barcelona

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hospital ICO Bellvitge

City

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital Universitario Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Virgen Del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital La Fe Valencia

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Sahlgrenska Universitetssjukhuset

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Skane University Hospital

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Onkologiska Kliniken

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Cambridge University Hospitals NHS Foundation Trust

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

University College London Hospitals

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

The Royal Marsden NHS Foundation Trust

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

The Christie

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35394800

Citation

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.

Results Reference

derived

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Selinexor in Advanced Liposarcoma

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