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Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 1 of 18 sitesv10
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 18 of 18 sites
    v9
  3. Study sites: 17 to 18v8
  4. Primary completion date: Jul 1, 2028 to Jul 1, 2029v7
  5. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Sep 15, 2025 to Aug 3, 2025
    • Site contacts updated at 17 of 17 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Aug 15, 2025 to Sep 15, 2025v5
  2. Start date: Jul 1, 2025 to Aug 15, 2025v4
  3. Start date: Jun 1, 2025 to Jul 1, 2025v3 Show 5 more changesShow less
    • Primary completion date: Jun 1, 2028 to Jul 1, 2028
    • Eligibility criteria shortened, about 121 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 113 words
    • Site contacts updated at 2 of 17 sites
  4. Primary completion date: Sep 1, 2027 to Jun 1, 2028
    • Start date: Sep 1, 2024 to Jun 1, 2025
    • Study completion date: Sep 1, 2034 to Jun 1, 2035
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
Trial Details
NCT Number NCT06333899
Lead Sponsor Nationwide Children's Hospital
Collaborators: Pfizer
Conditions
(from sponsor)		 High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma, Glioblastoma, Glioblastoma Multiforme, WHO Grade III Glioma, WHO Grade IV Glioma +1 more
Related terms Astrocytoma, Diffuse Intrinsic Pontine Glioma, Glioblastoma, Glioma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov