Cobimetinib for Arteriovenous Malformations
Trial Summary
Will I have to stop taking my current medications?
The trial requires you to stop taking strong inducers or inhibitors of CYP3A4, such as certain antibiotics and herbal supplements, at least 14 days before starting the study. If you are on any chemotherapy, immunotherapy, or targeted therapy, you must have completed it and recovered from any side effects at least 28 days before joining the trial.
What data supports the effectiveness of the drug Cobimetinib for treating arteriovenous malformations?
Cobimetinib, when combined with vemurafenib, has been shown to improve survival and tumor response rates in patients with a specific type of skin cancer (melanoma) that has a BRAF V600 mutation. While this data is specific to melanoma, it suggests that Cobimetinib can be effective in targeting certain pathways involved in tumor growth.12345
Is cobimetinib safe for humans?
How does the drug Cobimetinib differ from other treatments for arteriovenous malformations?
Cobimetinib is unique because it targets the MEK pathway, which is part of the RAS/RAF/MEK/ERK signaling cascade often involved in arteriovenous malformations with KRAS mutations. This approach is novel as it uses a mechanism similar to that of cancer treatments, focusing on specific genetic mutations rather than traditional surgical or embolization methods.910111213
What is the purpose of this trial?
The purpose of this open-label study is to evaluate the safety and efficacy of cobimetinib in extracranial AVM.
Research Team
Joana M Mack, MD
Principal Investigator
University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Kevin J Bielamowicz, MD,
Principal Investigator
University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cobimetinib for 21 days followed by 7 days off in a 28-day cycle, repeated for 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cobimetinib
Cobimetinib is already approved in European Union, United States, Canada, Switzerland, Japan for the following indications:
- Melanoma
- Melanoma
- Melanoma
- Melanoma
- Melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD