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Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

Study acronym: Briga-PED
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2029 to Dec 2033
    • Study completion date: Dec 2030 to Dec 2033
    • Site details revised at 2 of 2 sites
    v5
  2. Study sites: 1 to 2
    • Start date changed from estimate of Aug 31, 2022 to Aug 18, 2022
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2022 to Aug 31, 2022
    • Study sites: 0 to 1
    v3
  4. Start date: Dec 2021 to May 2022v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.
Trial Details
NCT Number NCT04925609
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: Takeda
Conditions
(from sponsor)		 Anaplastic Large Cell Lymphoma, ALK-Positive, Inflammatory Myofibroblastic Tumor, Other Solid Tumor
Related terms Granuloma, Plasma Cell, Lymphoma, Large-Cell, Anaplastic
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov