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Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)

Study acronym: INTUITT-NF2
StatusRecruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv14
  2. Trial status changed: Active, Not Recruiting → Recruitingv13 Show 7 more changesShow less
    • Trial arms changed: 2 → 3
    • Enrollment target: 100 to 109
    • Interventions: Brigatinib (Drug), Neratinib (Drug) to Bevacizumab (Drug), Brigatinib (Drug), Neratinib (Drug), Retifanlimab (Drug)
    • Eligibility criteria expanded, about 923 words
    • Study description expanded, about 188 words
    • Site details revised at 6 of 6 sites
    • Collaborators: 3 to 4
  3. Study sites revised (6)v12
  4. Re-verified, no change to tracked fieldsv11
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2029 to Dec 1, 2029
    • Study completion date: Dec 2030 to Dec 1, 2030
    • Site details revised at 6 of 6 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria expanded, about 3 words
    • Study description shortened, about 3 words
    v9
  2. Enrollment target: 80 to 100
    • Primary completion date: Dec 1, 2029 to Dec 2029
    • Study completion date: Dec 1, 2030 to Dec 2030
    • Study title expanded, about 2 words
    v8
  3. Study description expanded, about 13 wordsv7
  4. Interventions: Brigatinib (Drug) to Brigatinib (Drug), Neratinib (Drug)v6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 777 words
    • Study description expanded, about 165 words
    • Collaborators: 2 to 3
    • Study arms: 1 to 2
  5. Study sites: 5 to 6v5
  6. Study sites: 3 to 5v4
  7. Study sites: 2 to 3v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2020 to Jun 20, 2020
    • Site details revised at 2 of 2 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2-SWN to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. * Investigational Drug Sub-study A: Brigatinib * Investigational Drug Sub-study B: Neratinib * Investigational Drug Sub-study C: Retifanlimab plus bevacizumab
Trial Details
NCT Number NCT04374305
Lead Sponsor Scott R. Plotkin, MD, PhD
Collaborators: Takeda, The Children's Tumor Foundation, National Comprehensive Cancer Network, Incyte Corporation
Conditions
(from sponsor)		 Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma
Related terms Ependymoma, Meningioma, Neurofibromatosis 2, Neuroma, Acoustic
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov