Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04258046
Phase
PHASE2
Status
Completed

Conditions

  • Arterial Disease
  • Venous Malformation

Eligibility Criteria

Sex
ALL
Age
12 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Dec 1, 2020
Status verified
Apr 2026
Primary completion
Feb 2, 2026
Completion
Feb 18, 2026

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Trametinib
    Patients will receive oral trametinib once daily

Primary Outcome Measure

Disease response rate by investigator assessment at Month 6 [ Time Frame: Month 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pediatric Dermatology Clinic at Stanford Children's HospitalPalo AltoCalifornia94304-

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Pediatric Dermatology Clinic at Stanford Children's Hospital· Palo Alto, CA

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