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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Study Summary

This trial is testing a new drug to treat AVM, a congenital vascular anomaly. AVM can cause tissue destruction, bleeding, functional deficits, deformity, and cardiac failure. The new drug is being tested for safety and efficacy in children and adults.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease response rate by investigator assessment at Month 6
Secondary outcome measures
Change from baseline in MRI Volumetric Scan Measurement of Targeted Disease Area
Disease response rate by investigator assessment at Month 12

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,292 Total Patients Enrolled
3 Trials studying Arteriosclerosis
1,105 Patients Enrolled for Arteriosclerosis
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,700 Total Patients Enrolled
Joyce Teng, MD, PhD, FAADPrincipal InvestigatorStanford University

Media Library

Trametinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04258046 — Phase 2
Trametinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258046 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollments being accepted currently for this experiment?

"According to clinicaltrials.gov, this medical research project is actively recruiting. The trial was published on December 1st 2020 and the most recent update occurred in February 25th 2022."

Answered by AI

How many participants are enrolled in this medical trial?

"Affirmative. Data available on clinicaltrials.gov indicates that this medical trial is presently in search of participants, with the original post being made on December 1st 2020 and most recently updated on February 25th 2022. This research requires 30 patients to be recruited from one site alone."

Answered by AI

How can I become a participant in this experiment?

"This trial is actively seeking 30 individuals between the ages of 12 and 60 that have been diagnosed with a fetal abnormality. Eligible participants must also meet these additional conditions: MAP2K1 genetic testing or RAS/MAPK pathway mutation analysis (preferred but not compulsory), any necessary clinical and laboratory examinations to verify eligibility should be completed within six weeks, at least four weeks since major surgery, endocrine deficiency patients may receive appropriate doses of corticosteroids if needed, 14 days from completion of biologic therapy (or longer depending on adverse effects profile) and candidates who had undergone AVM resection or sclerotherapy can still"

Answered by AI

Does this study accept participants aged 50 or older?

"This clinical trial has regulations that stipulate the minimum age of enrolment is 12, while participants must be under 60 years old to qualify."

Answered by AI

What potential perils accompany Trametinib tablet consumption?

"Trametinib tablet has been allotted a safety score of 2 by the team at Power, due to this being a Phase 2 trial with evidence only confirming its security rather than efficacy."

Answered by AI

What other investigations have been conducted pertaining to Trametinib tablet?

"Currently, there are 92 research initiatives exploring the efficacy of Trametinib tablets. Of those trials, 6 have advanced to Phase 3. Despite being primarily conducted in Saint Louis, Missouri; this drug is being investigated at 5794 locations worldwide."

Answered by AI
Recent research and studies
~5 spots leftby Dec 2024