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A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Study acronym: TARGET-VM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Aug 2026 to Jan 2027 Completion pushed from Dec 2026 to May 2027v10 Show 1 more changeShow less
    • Completion pushed from Dec 2026 to May 2027
  2. Site contacts updated at 1 of 2 sitesv9
  3. Site details revised at 1 of 2 sitesv8
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2024 to Sep 13, 2024 · Site details revised at 2 of 2 sitesv7 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2024 to Sep 13, 2024
    • Site details revised at 2 of 2 sites
  5. Start date: Aug 2024 to Oct 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Apr 2024 to Aug 2024 Primary completion date: Jun 2026 to Aug 2026 · Completion date: Nov 2026 to Dec 2026v5 Show 2 more changesShow less
    • Primary completion date: Jun 2026 to Aug 2026
    • Completion date: Nov 2026 to Dec 2026
  2. Enrollment target: 30 to 50 Start date: Sep 2023 to Apr 2024 · Primary endpoint revised · Primary completion date: Sep 2026 to Jun 2026 · 5 morev4 Show 8 more changesShow less
    • Start date: Sep 2023 to Apr 2024
    • Primary endpoint revised
    • Primary completion date: Sep 2026 to Jun 2026
    • Completion date: Sep 2028 to Nov 2026
    • Eligibility criteria expanded, about 1,196 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description revised
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites revised (2)v3 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).
Trial Details
NCT Number NCT05983159
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Peter MacCallum Cancer Centre, Australia, Royal Children's Hospital
Conditions Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous Malformation, Lymphatic Malformation, Low Flow, Lymphatic Malformation, Lymphangioma, Arteriovenous Malformations +10 more
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov