Pilot Study on Trametinib for Surgical Unruptured AVMs (NCT06098872) | Clinical Trial Compass
WithdrawnPhase 2
Pilot Study on Trametinib for Surgical Unruptured AVMs
Stopped: No patients enrolled
Canada0Started 2024-01-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years.
. Confirmed diagnosis of an unruptured AVM Spetzler-Martin Lawton Young Grade equal to or less than 6 on magnetic resonance imaging (MRI), CT-angiogram (CTA) or angiogram, and clinical exam by a physician who is familiar with this condition at any time in patient's medical history.
. Planned surgical resection of AVM at University Health Network within the acceptable window defined by the study calendar (i.e. after the indicated study drug dosing period and approximate week-long follow up).
. Patients must not have received an investigational drug within the 4 weeks prior to study enrolment.
. Patients who have previously received biologic therapy treatment must have completed therapy at least 14 days prior to study enrolment.
. Patients who have previously received myelosuppressive chemotherapy must have completed therapy at least 28 days prior to study enrolment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiological response by independent central review at day 60 or 5 days after last dose, whichever comes first
Timeframe: screening, Day 60 or 5 days after last dose (whichever comes first)
. Patients on anticoagulants must have stopped treatment within 7 days of starting Trametinib.
. Patient is able to swallow oral medication and/or retain oral medication via G tube.
Exclusion criteria
. AVM due to known germline mutation such as phosphatase and tensin homolog (PTEN) or known history of familial AVM syndromes.
. Received prior map kinase (MEK) inhibitor therapy.
. Known allergy or contraindication to MEK inhibitor treatment.
. Patients who have undergone major surgery, as defined by the overseeing Investigator, within 28 days prior to study enrolment or who have not recovered from side effects of such a procedure.
. Patients that are currently pregnant or breastfeeding.
. A known history of coagulopathy and/or current use of anticoagulant therapy.
. International normalized ratio (INR) \> 1.5 within 7 days of enrolment.
. Left ventricular ejection fraction (LVEF) \<50%, or any ECG abnormalities within 7 days of enrolment.