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MEK Inhibitor
Cobimetinib for Arteriovenous Malformations
Phase 2
Recruiting
Led By Joana M Mack, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must also agree not to donate eggs (female patients) or sperm (male patients) during this study and for at least 3 months after the last dose of cobimetinib
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN for age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will test whether a drug called cobimetinib is safe and effective in treating people with extracranial arteriovenous malformations (AVMs).
Who is the study for?
This trial is for people aged 2-80 with extracranial arteriovenous malformations (AVMs). Participants must be able to take oral medication, have a certain level of physical functioning, and normal organ function. Women who can get pregnant must use two forms of birth control and provide negative pregnancy tests. People with active cancer, severe allergies to cobimetinib components, recent infections or surgeries, heart problems, HIV, CNS hemorrhage history or those on certain medications are excluded.Check my eligibility
What is being tested?
The COBI-AVM study is testing the safety and effectiveness of cobimetinib in treating AVMs located outside the brain. It's an open-label trial where all participants know they're receiving the drug. The goal is to see how well it works and what side effects occur when used for this condition.See study design
What are the potential side effects?
Cobimetinib may cause side effects such as diarrhea, rash, liver enzyme elevation indicating potential liver damage, muscle spasms or pain; eye problems like blurred vision; fatigue; nausea; fever; allergic reactions including skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate eggs or sperm during and for 3 months after the study.
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My bilirubin levels are within the normal range for my age.
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I am between 2 and 80 years old.
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I can take medicine by mouth or through a feeding tube.
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My kidney function is within the normal range for my age and gender.
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I am mostly able to care for myself and carry out daily activities.
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My liver tests are within normal range for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) or partial response (PR) rate compared to Baseline
Side effects data
From 2024 Phase 2 trial • 86 Patients • NCT0320145874%
Disease Progression
47%
Fatigue
35%
Aspartate aminotransferase (AST) increased
33%
Abdominal pain
33%
Diarrhea
30%
Hypertension
30%
Lymphocyte count decreased
30%
Anemia
28%
Hyponatremia
28%
Alkaline phosphatase increased
28%
Nausea
26%
Hypoalbuminemia
26%
Hypokalemia
23%
Alanine aminotransferase (ALT) increased
23%
Vomiting
21%
Fever
21%
Platelet count decreased
21%
Anorexia
21%
Cough
19%
Pain
16%
Blood bilirubin increased
16%
Constipation
16%
White blood cell decreased
14%
Dyspnea
14%
Creatinine increased
12%
Hypomagnesemia
12%
Bloating
12%
Chills
12%
Dehyrdation
12%
Weight loss
9%
Hypothyroidism
9%
Rash
9%
Dizziness
9%
Edema
9%
Headache
9%
Infusion-related reaction
9%
Hypotension
9%
Ascites
7%
Back pain
7%
Hypophosphotemia
7%
Allergic reaction
7%
Neutrophil count decreased
7%
Dyspepsia
7%
Thrush
7%
Hypercalcemia
7%
Hyperglycemia
5%
Hypocalcemia
5%
Myalgia
5%
Gastric obstruction
5%
Insomnia
5%
Malaise
5%
Proteinuria
5%
Allergic rhinitis
5%
Dysgeusia
5%
Dysphagia
5%
Flatulence
5%
Generalized muscle weakness
5%
Non-cardiac chest pain
5%
Oral pain
5%
Peripheral neuropathy
5%
Pleural effusion
5%
Pruritus
5%
Sinus tachycardia
5%
Colitis
5%
Death NOS
5%
Abdominal distension
5%
Anxiety
5%
Arthralgia
5%
Hyperhidrosis
2%
Gastroesophageal reflux disease (GERD)
2%
Biliary tract infection
2%
Presyncope
2%
Myocarditis
2%
Biliary duct obstruction
2%
Hyperkalemia
2%
Syncope
2%
Cardiac troponin increased
2%
Duodenal obstruction
2%
Lipase increased
2%
Pleuritic pain
2%
Edema limbs
2%
Encephalopathy
2%
Hypoxia
2%
Ileal obstruction
2%
Myocardial infarction
2%
Sepsis
2%
Ureteral obstruction
2%
Urinary retention
2%
Dry mouth
2%
Dry skin
2%
Sinus bradycardia
2%
Sore throat
2%
Bacteremia
2%
Fungemia
2%
Infusion related reaction
2%
Meningitis
2%
Peritoneal infection
2%
Viral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Atezolizumab)
Arm B (Atezolizumab, Cobimetinib)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Investigational DrugExperimental Treatment1 Intervention
Cobimetinib will be administered at a maximal dose of 60 mg daily for 21 days on, then 7 days off, in a 28-Day treatment cycle for 12 cycles (approximately 12 months). Cobimetinib should be taken once daily at approximately the same time each day, and no later than 4 hours after the scheduled time. Cobimetinib can be taken with or without a meal. Cobimetinib tablets should never be chewed, cut, or crushed. Therapy may continue for up to 12 cycles provided the subject meets the criteria for starting subsequent cycles and does not meet any of the criteria for cobimetinib discontinuation. At least 7 days off cobimetinib (within +7 days) is required prior to starting a new treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~3090
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,014 Total Patients Enrolled
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,274 Total Patients Enrolled
1 Trials studying Arteriovenous Malformations
56 Patients Enrolled for Arteriovenous Malformations
Joana M Mack, MDPrincipal InvestigatorUniversity of Arkansas for Medical Sciences, Arkansas Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Drug
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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