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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 : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 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 222 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  • selinexor, will be withdrawn from further treatment and followed for survival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 : Interventional  (Clinical Trial)
Estimated Enrollment : 279 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)
Study Start Date : December 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selinexor 60mg

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

Phase 3: Approximately 222 patients will be randomized to selinexor (~148 patients) or placebo (~74 patients) in a 2:1 allocation.

Drug: Selinexor
Selinexor 60mg
Other Name: KPT-330

Placebo Comparator: Placebo

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

Phase 3: Approximately 222 patients will be randomized to selinexor (~148 patients) or placebo (~74 patients) in a 2:1 allocation.

Drug: Placebo
Other Name: sugar pill




Primary Outcome Measures :
  1. 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. ]


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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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606461


Contacts
Contact: Michael Kauffman, M.D., Ph.D. Mkauffman@karyopharm.com
Contact: Sharon Shacham, PhD sshacham@karyopharm.com

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Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc

Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02606461     History of Changes
Other Study ID Numbers: KCP-330-020
2015-003594-14 ( EudraCT Number )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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