NCT05125471

Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)

COBI-AVM Study - Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib In Extracranial Arteriovenous Malformations (AVM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label study is to evaluate the safety and efficacy of cobimetinib in extracranial AVM.

Detailed description

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).

Conditions

• Arteriovenous Malformations (Extracranial)

Interventions

Type	Name	Description
DRUG	Cobimetinib	Adult dosing (\>/= 18 years old) will be 60 mg orally once daily (tablet formulation); Pediatric dosing (\<18 years old) will be 1 mg/kg/dose (maximum 60 mg per dose) orally once daily (oral suspension formulation).

Timeline

• Start date: 2022-07-26
• Primary completion: 2025-09-03
• Completion: 2025-09-03
• First posted: 2021-11-18
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study