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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Study acronym: SENTRY
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 5 entries Eligibility criteria expanded, about 9 words · Study sites revised (166) · Publications: details revised at 3 of 3 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study sites revised (166)
    • Publications: details revised at 3 of 3 entries
  2. Primary completion date changed from estimate of Mar 2026 to Feb 20, 2026 Site details revised at 1 of 166 sitesv26 Show 1 more changeShow less
    • Site details revised at 1 of 166 sites
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 350 to confirmed 353 · Study sites: 149 to 166 · Primary completion date: Sep 2025 to Mar 2026v25 Show 3 more changesShow less
    • Enrollment target: estimated 350 to confirmed 353
    • Study sites: 149 to 166
    • Primary completion date: Sep 2025 to Mar 2026
  4. Primary endpoints revised (5) Enrollment target: 330 to 350 · Study sites: 137 to 149 · Eligibility criteria shortened, about 761 words · 1 morev24 Show 4 more changesShow less
    • Enrollment target: 330 to 350
    • Study sites: 137 to 149
    • Eligibility criteria shortened, about 761 words
    • Secondary endpoints: 27 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints revised (5) Study sites: 96 to 137 · Eligibility criteria expanded, about 35 words · Secondary endpoints: 25 to 27v23 Show 3 more changesShow less
    • Study sites: 96 to 137
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 25 to 27

    See this version in full on ClinicalTrials.gov ↗

Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 79 to 96v22
  2. Study sites: 60 to 79v21
  3. Study sites: 38 to 60v20
  4. Study sites: 19 to 38v19
  5. Re-verified, no change to tracked fieldsv18
  6. Study sites: 11 to 19v17
  7. Study sites: 7 to 11v16
  8. Study sites: 6 to 7v15
  9. Re-verified, no change to tracked fieldsv14
  10. Study sites: 5 to 6v13
  11. Completion date: Dec 2027 to Mar 2028v12
  12. Phase: Phase 1/2 to Phase 3 Primary completion date: Nov 2023 to Sep 2025 · Primary endpoints: 4 to 5 · Enrollment target: 237 to 330 · 7 morev11 Show 10 more changesShow less
    • Primary completion date: Nov 2023 to Sep 2025
    • Primary endpoints: 4 to 5
    • Enrollment target: 237 to 330
    • Completion date: Nov 2024 to Dec 2027
    • Interventions: Ruxolitinib (Drug), Selinexor (Drug) to Placebo (Other), Ruxolitinib (Drug), Selinexor (Drug), Selinexor (Drug)
    • Eligibility criteria expanded, about 348 words
    • Secondary endpoints: 13 to 25
    • Site details revised at 4 of 5 sites
    • Study title shortened, about 8 words
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  13. 3 versions Re-verified since May 2, 2022, no change to tracked fieldsv8-v10
  14. Study sites: 4 to 5v7
  15. Study sites: 2 to 4v6
  16. Study sites: 9 to 2v5
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 9 · Start date changed from estimate of Mar 2021 to Mar 11, 2021v4 Show 2 more changesShow less
    • Study sites: 0 to 9
    • Start date changed from estimate of Mar 2021 to Mar 11, 2021
  18. Start date: Nov 2020 to Mar 2021v3
  19. Enrollment target: 193 to 237 Eligibility criteria expanded, about 103 words · Secondary endpoints: 11 to 13v2 Show 2 more changesShow less
    • Eligibility criteria expanded, about 103 words
    • Secondary endpoints: 11 to 13

    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.
This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.
Trial Details
NCT Number NCT04562389
Lead Sponsor Karyopharm Therapeutics Inc
Conditions Myelofibrosis
Enrollment 353 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov