Clinical Trials /

Selinexor in Advanced Liposarcoma

NCT02606461

Description:

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).

Related Conditions:
  • Dedifferentiated Liposarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Selinexor in Advanced Liposarcoma
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: KCP-330-020
  • SECONDARY ID: 2015-003594-14
  • NCT ID: NCT02606461

Conditions

  • Dedifferentiated Liposarcoma

Interventions

DrugSynonymsArms
SelinexorKPT-330Selinexor 60mg
Placebosugar pillPlacebo

Purpose

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).

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        -  selinexor, will be withdrawn from further treatment and followed for survival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

Trial Arms

NameTypeDescriptionInterventions
Selinexor 60mgExperimentalPhase 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.
  • Selinexor
PlaceboPlacebo ComparatorPhase 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.
  • Placebo

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Karyopharm Therapeutics Inc

Trial Keywords

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

Last Updated

November 6, 2019