Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Exclusion Criteria

• •AVM due to germline mutation such as PTEN
• •Prior MEK inhibitor therapy or have allergy or contraindication to MEK inhibitor
• •Unable to swallow PO drugs or administer the drug via G tube
• •Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such procedure
• •Patients with evidence of or history of cardiovascular risk
• •Patients with retinal vein occlusion, hemorrhage or have a history of such conditions.
• •Patients who are currently on other immunosuppressive medication(s)
• •Patients who have an uncontrolled infection
• •Unstable health status that may interfere with completing study
• •Unable to travel to clinic as requested
• •Patients unwilling or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
• •Females of child-bearing potential must be willing to practice acceptable methods of birth control.
• •Additionally, females of childbearing potential must have a negative serum pregnancy test result from 7 days prior to the initiation of the medication to 3 months after the final administration of the medication. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period when they are receiving the study drug and for 3 months thereafter.