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Cobimetinib for Arteriovenous Malformations
Study Summary
This trial will test whether a drug called cobimetinib is safe and effective in treating people with extracranial arteriovenous malformations (AVMs).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 86 Patients • NCT03201458Trial Design
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- I have been diagnosed with chronic HIV.I haven't taken strong CYP3A4 drugs in the last 14 days.I am currently pregnant or breastfeeding.I have had an infection in the last 28 days that is not fully resolved.I agree not to donate eggs or sperm during and for 3 months after the study.I haven't taken long-acting blood cell boosters in the last 14 days or short-acting ones in the last 7 days.I've taken low-dose steroids but will stop 14 days before the study starts.I do not have serious eye conditions or risks for eye blood vessel blockage.I have heart failure symptoms that affect my daily activities.You have had a serious allergic reaction to any parts of cobimetinib in the past.I have an AVM outside the brain with measurable size and can provide a previous biopsy report or will undergo a biopsy.Your platelet count should be at least 75 x 10^9 per liter of blood, and you should not have received a blood transfusion in the past 7 days.I have not had a serious brain bleed or any brain bleed in the last 28 days.I have or had another type of cancer.I haven't had new or worsening chest pain in the last 3 months.I have had major bowel surgery affecting my nutrient absorption.I agree to use two forms of birth control or practice true abstinence during and 3 months after the study.My heart's pumping ability is normal, as confirmed by a recent heart scan.I am between 2 and 80 years old.I do not have serious heart rhythm problems or need medication for it.I can take medicine by mouth or through a feeding tube.I am a woman who can have children and have taken a pregnancy test with negative results before starting treatment.My bilirubin levels are within the normal range for my age.My kidney function is within the normal range for my age and gender.I am mostly able to care for myself and carry out daily activities.I have had pneumonitis before.My liver tests are within normal range for my age.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have not had a heart attack in the last 3 months.I experience uncontrollable nausea and vomiting, have issues absorbing nutrients, or have an external biliary shunt.I finished my last cancer treatment over 28 days ago and have no major side effects.I haven't taken any cancer treatments or herbal therapies in the last 28 days or 5 half-lives, whichever is longer.Your hemoglobin level is at least 8 grams per deciliter and you haven't had a blood transfusion in the past 7 days.Your white blood cell count is above a certain level without needing medication to increase it in the past week.
- Group 1: Investigational Drug
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants being enrolled in this clinical trial at present?
"Yes, clinicaltrials.gov has the latest information on this trial which is still recruiting patients. The listing was created on 7/26/2022 and edited on 8/30/2022. They are looking for a total of 17 individuals at 1 medical site."
Are middle-aged adults eligible for this research program?
"According to the eligibility requirements, patients that are aged 2 to 80 may apply for this study. There have been 64 similar studies completed with children and 144 with elderly patients."
Does Cobimetinib have any potentially harmful side effects?
"There is some data supporting Cobimetinib's safety, but none yet confirming its efficacy. Therefore, it received a score of 2."
Do you have any prior experience with Cobimetinib?
"Cobimetinib is currently being studied in 57 clinical trials, 3 of which are Phase 3 studies. Many of the investigations for this drug are based out of Portland, Oregon; however, there are 1474 different locations running these tests."
Has this research been conducted before?
"Cobimetinib has a long clinical history, with the first study taking place in 2013. Since then, there have been 57 active studies involving this drug across 353 cities and 49 countries."
How many people are being given the opportunity to participate in this clinical trial?
"That is correct, according to the clinicaltrials.gov website, this trial is still looking for patients. The posting went up on 7/26/2022 and was last updated a month ago on 8/30/2022. They are currently 17 people short of their goal number across 1 location."
Who does this clinical trial require as participants?
"In order to meet the requirements for this clinical trial, potential participants must have fetal anomalies and fall in the age range of 2 to 80. A total of 17 individuals can take part in this study."
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