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A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Study acronym: SENTRY-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 118 to 58 Primary completion date: Apr 2026 to Jun 2027 · Primary endpoint revised · Study sites: 48 to 70 · 3 morev10 Show 6 more changesShow less
    • Primary completion date: Apr 2026 to Jun 2027
    • Primary endpoint revised
    • Study sites: 48 to 70
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 19 to 2
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 21 to 48v9
  3. Study sites: 5 to 21v8
  4. Study sites: 3 to 5v7
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Apr 2024 to Apr 22, 2024v6 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 2024 to Apr 22, 2024
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoint revised Start date: Mar 2024 to Apr 2024 · Secondary endpoints revised (19)v5 Show 2 more changesShow less
    • Start date: Mar 2024 to Apr 2024
    • Secondary endpoints revised (19)

    See this version in full on ClinicalTrials.gov ↗

  2. Study title shortened, about 1 wordv4 See this version in full on ClinicalTrials.gov ↗
  3. Primary endpoint revised Interventions: Selinexor (Drug), Selinexor (Drug) to Momelotinib (Drug), Pacritinib (Drug), Ruxolitinib (Drug), Selinexor 40 mg (Drug), Selinexor 60 mg (Drug) · Eligibility criteria shortened, about 13 words · Secondary endpoints revised (19)v3 Show 3 more changesShow less
    • Interventions: Selinexor (Drug), Selinexor (Drug) to Momelotinib (Drug), Pacritinib (Drug), Ruxolitinib (Drug), Selinexor 40 mg (Drug), Selinexor 60 mg (Drug)
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints revised (19)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoint revised Interventions: Selinexor (Drug) to Selinexor (Drug), Selinexor (Drug) · Secondary endpoints: 12 to 19 · Study arms: 2 to 4v2 Show 3 more changesShow less
    • Interventions: Selinexor (Drug) to Selinexor (Drug), Selinexor (Drug)
    • Secondary endpoints: 12 to 19
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
Trial Details
NCT Number NCT05980806
Lead Sponsor Karyopharm Therapeutics Inc
Conditions Myelofibrosis, Moderate Thrombocytopenia, Mild Thrombocytopenia
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov