Pilot Study on Trametinib for Surgical Unruptured AVMs

Sponsor
University Health Network, Toronto
Study ID
NCT06098872
Phase
PHASE2
Status
Withdrawn

Conditions

  • Arteriovenous Malformations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Arteriovenous malformation (AVM) is a tangle of abnormal vessels that can progress through life and cause significant bleeding, deformity, pain, and deficits in day-to-day activities. Surgery is a common treatment option for patients with AVMs where the goal is to safely remove the entire AVM without causing complications. While any surgery has its potential risks, most of the potential modifiable risk factors relate to the AVM's structure, such as the AVM size or presence of high risk structural features seen on scans. The purpose of this pilot study is to see whether taking an oral medication called Trametinib can improve upon the AVM structure in adult patients before their scheduled surgery.

Key Dates

Start date
Jan 30, 2024
Status verified
Oct 2023
Primary completion
Mar 26, 2026
Completion
Mar 26, 2026

Study Design

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

Arms

  • Experimental: Experimental: Oral Trametinib
    Participants will receive oral Trametinib once daily for up to 60 days prior to their elective surgery

Primary Outcome Measure

Radiological response by independent central review at day 60 or 5 days after last dose, whichever comes first [ Time Frame: screening, Day 60 or 5 days after last dose (whichever comes first) ]

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