University of Arkansas
The purpose of this open-label study is to evaluate the safety and efficacy of cobimetinib in extracranial AVM.
Arteriovenous Malformations (Extracranial)
Cobimetinib
Phase 2
After being informed of the study and potential risks, all patients giving informed consent will go undergo a screening period to determine eligibility for study entry. Patients who meet the eligibility requirements will be given cobimetinib to take by mouth once daily at the same time each day for 21 days and then have 7 days with no treatment. Patients will receive cobimetinib as a tablet (adult) or as a liquid (child).}}
Study Type : | Interventional |
Estimated Enrollment : | 17 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | COBI-AVM Study - Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib In Extracranial Arteriovenous Malformations (AVM) |
Actual Study Start Date : | July 26, 2022 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Investigational Drug 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. |
Drug: Cobimetinib |
Ages Eligible for Study: | 2 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Arkansas Children's Hospital
Little Rock, arkansas, United States, 72202