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Trial record 1 of 1 for:    selinexor and phase 3 and liposarcoma
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Selinexor in Advanced Liposarcoma (SEAL)

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ClinicalTrials.gov Identifier: NCT02606461
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE November 17, 2015
Last Update Posted Date March 11, 2020
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo. [ Time Frame: From the date of randomization until the first date of disease progression, per RECIST v1.1 Response Criteria, or death due to any cause; up to approximately 30 months. ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2015)
  • Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
  • Primary analysis of PFS -performed on the intent-to-treat (ITT) population. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 12 months. ]
    Phase 2 PFS data will inform adjustment of the Phase 3 sample size
  • Time to progression (TTP) [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
  • Quality of Life as measured by the EORTC QLQ-C30 total score. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
    For EORTC QLQ-C30, the transformed score will be used, calculated according to the EORTC QLQ-C30 Scoring Manual.
  • Quality of Life as measured by the EQ-5D-5L category scores and total score. [ Time Frame: From the date of randomization until the first date of disease progression, per WHO Response Criteria, or death due to any cause; up to approximately 30 months. ]
    For the EQ-5D-5L questionnaire, the overall health score will be used.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selinexor in Advanced Liposarcoma
Official Title  ICMJE A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Brief Summary This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 334 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 277 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dedifferentiated Liposarcoma
Intervention  ICMJE
  • Drug: Selinexor
    Selinexor 60mg
    Other Name: KPT-330
  • Drug: Placebo
    Other Name: sugar pill
Study Arms  ICMJE
  • Experimental: Selinexor 60mg

    Phase 2: 57 patients were randomized to selinexor or placebo in a 1:1allocation.

    Phase 3: Approximately 277 patients will be randomized to selinexor (~185 patients) or placebo (~92 patients) in a 2:1 allocation.

    Intervention: Drug: Selinexor
  • Placebo Comparator: Placebo

    Phase 2: Approximately 57 patients were randomized to selinexor or placebo in a 1:1 allocation.

    Phase 3: Approximately 277 patients will be randomized to selinexor (~185 patients) or placebo (~92 patients) in a 2:1 allocation.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
334
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2015)
245
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 two (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 less than or equal to Grade 1

Exclusion Criteria:

  1. Patients with pure 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Kauffman, M.D., Ph.D. Mkauffman@karyopharm.com
Contact: Sharon Shacham, PhD sshacham@karyopharm.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02606461
Other Study ID Numbers  ICMJE KCP-330-020
2015-003594-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Karyopharm Therapeutics Inc
Study Sponsor  ICMJE Karyopharm Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
PRS Account Karyopharm Therapeutics Inc
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP