NCT04258046

Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Phase II Clinical Trial of MEK Inhibitor Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation (VM)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Arteriovenous malformation (AVM) is a congenital vascular anomaly that progresses throughout life and causes complications including tissue destruction due to rapid overgrowth, bleeding, functional deficits, severe deformity and cardiac failure. Unfortunately, traditional managements have transient benefits with more than 90 recurrence rate within a year. Therefore, there is a significant unmet medical need. The purpose of this study is to assess the safety and efficacy of Trametinib in children and adults with Extracranial Arteriovenous Malformation (AVM).

Conditions

• Venous Malformation
• Arterial Disease

Interventions

Type	Name	Description
DRUG	Trametinib tablet	Drug is supplied in 0.5 mg and 2 mg tablets

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-02-06
• Last updated: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study