What side effects are associated with this type of intervention?

Common treatments for arteriosclerosis include statins, antiplatelet agents, and anticoagulants. Statins can cause muscle pain, liver damage, and increased blood sugar levels. Antiplatelet agents, such as aspirin, may lead to gastrointestinal bleeding and increased risk of hemorrhagic stroke. Anticoagulants can cause bleeding complications and require regular monitoring. While Trametinib (a MEK inhibitor) is not typically used for arteriosclerosis, its known side effects in other conditions include rash, diarrhea, and fatigue. Overall, the side effects of arteriosclerosis treatments vary but often involve bleeding risks and metabolic disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for arteriosclerosis, primarily focusing on lipid-lowering agents, antiplatelet drugs, and antihypertensive medications. Statins, such as atorvastatin and rosuvastatin, are commonly used to lower cholesterol levels and reduce cardiovascular risk. Antiplatelet agents like aspirin and clopidogrel help prevent blood clots. Antihypertensive drugs, including ACE inhibitors and beta-blockers, manage blood pressure to reduce arterial stress. While Trametinib, a MEK inhibitor, is being studied for vascular anomalies, it is not yet a standard treatment for arteriosclerosis. Current treatments do not typically include MEK inhibitors.

What other types of research exist?

Promising novel alternatives to Trametinib for arteriosclerosis patients include PI3K inhibitors, mTOR inhibitors like everolimus, and other targeted therapies such as tyrosine kinase inhibitors. These agents have shown potential in clinical trials for related vascular conditions and may offer new avenues for treatment.

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MEK Inhibitor

Trametinib for Arterial Venous Malformation

Phase 2

Recruiting

Led By Joyce Teng, MD, PhD, FAAD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Myelosuppressive chemotherapy: None within 4 weeks of entry into this study

Patient is able to swallow and/or retain oral medication via G tube

Must not have

Prior MEK inhibitor therapy or have allergy or contraindication to MEK inhibitor

AVM due to germline mutation such as PTEN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Trametinib, a medication that may help treat arteriovenous malformation (AVM), a condition where blood vessels grow abnormally. The study focuses on children and adults with AVM because current treatments often fail, with symptoms returning quickly. Trametinib works by blocking proteins that cause abnormal blood vessel growth.

Who is the study for?

This trial is for individuals aged 12-60 with a confirmed diagnosis of complicated extracranial AVMs. They must be able to take oral medication and have not received certain treatments like biologics, major surgery, or investigational drugs within specific time frames before enrollment. Women of childbearing potential must agree to use birth control.

What is being tested?

The study tests the safety and effectiveness of Trametinib tablets in treating Extracranial Arteriovenous Malformation (AVM), which can cause severe complications. The goal is to find a better treatment option than current therapies that often result in high recurrence rates.

What are the potential side effects?

Trametinib may cause side effects such as cardiovascular issues, bleeding problems including retinal vein occlusion, skin rash, fatigue, nausea and diarrhea. It might also affect liver enzymes and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had chemotherapy that lowers my blood cell counts in the last 4 weeks.

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I can take pills by mouth or through a G tube.

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I am between 12 and 60 years old.

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My AVM has not been in a radiation field in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously taken or am allergic to MEK inhibitor therapy.

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I have AVM caused by a genetic change.

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I am currently taking medication that suppresses my immune system.

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I have had issues with blood vessels in my eyes or bleeding inside my eyes.

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I cannot travel to the clinic as needed.

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I had major surgery less than 4 weeks ago or am still dealing with its side effects.

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I have a history of heart problems.

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I cannot take pills by mouth or use a G tube.

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I do not have any infections that are currently uncontrolled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease response rate by investigator assessment at Month 6

Secondary study objectives

Disease response rate by investigator assessment at Month 12

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral TrametinibExperimental Treatment1 Intervention

Patients will receive oral trametinib once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib tablet

2012

Completed Phase 1

~20

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for arteriosclerosis include statins, which inhibit HMG-CoA reductase to lower cholesterol levels and reduce inflammation, and anti-inflammatory agents like colchicine, which target inflammatory pathways to decrease cardiovascular events. These treatments are crucial for arteriosclerosis patients as they help stabilize plaques, reduce the risk of cardiovascular events, and improve overall vascular health. Similar to Trametinib, which inhibits the MEK pathway to reduce cellular proliferation and inflammation, these treatments aim to modulate key biological pathways involved in the progression of arteriosclerosis.

Current and emerging drugs for the treatment of atherosclerosis: the evidence to date.HMG-CoA reductase inhibitors (statins), inflammation, and endothelial progenitor cells-New mechanistic insights of atherosclerosis.Expression of c-fos, p53 and PCNA in the unstable atherosclerotic carotid plaque.