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(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 16 entries
    • Site details revised at 9 of 49 sites
    • Publications: details revised at 4 of 4 entries
  2. Study completion date: Jan 31, 2028 to Jun 23, 2027v19
  3. Re-verified, no change to tracked fieldsv18
  4. Primary completion date: Jun 21, 2022 to Jun 23, 2027
    • Primary endpoints: 2 to 3
    • Study completion date: Jan 31, 2027 to Jan 31, 2028
    • Secondary endpoints revised (16)
    v17
  5. Primary endpoints revised (2)
    • Primary completion date changed from estimate of Jun 2022 to Jun 21, 2022
    • Study completion date: Jan 2027 to Jan 31, 2027
    • Secondary endpoints: 15 to 16
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv15 Show 4 more changesShow less
    • Enrollment target: estimated 244 to confirmed 251
    • Primary completion date: Mar 2022 to Jun 2022
    • Study completion date: Dec 2024 to Jan 2027
    • Site details revised at 49 of 49 sites
  2. Study sites: 38 to 49v14
  3. Study sites: 35 to 38v13
  4. Primary completion date: May 2021 to Mar 2022
    • Study sites: 31 to 35
    v12
  5. Study sites: 22 to 31v11
  6. Study sites: 19 to 22v10
  7. Study sites: 14 to 19v9
  8. Enrollment target: 112 to 244v8 Show 5 more changesShow less
    • Primary endpoints: 4 to 2
    • Study completion date: Feb 2024 to Dec 2024
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 14 to 15
    • Study title shortened, about 2 words
  9. Primary completion date: Dec 2020 to May 2021
    • Study completion date: Nov 2023 to Feb 2024
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (14)
    v7
  10. Study sites: 10 to 14v6
  11. Study sites: 6 to 10v5
  12. Study sites: 5 to 6
    • Start date changed from estimate of Mar 2019 to Apr 16, 2019
    v4
  13. Study sites: 1 to 5
    • Start date: Jan 2019 to Mar 2019
    v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  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 Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.
Trial Details
NCT Number NCT03731260
Lead Sponsor Blueprint Medicines Corporation
Conditions
(from sponsor)		 Indolent Systemic Mastocytosis
Related terms Mastocytosis, Systemic
Enrollment 251 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov