MedTrace Logo

Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)

NCT05125471 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-10

No results posted yet for this study

Summary

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

Conditions

  • Arteriovenous Malformations (Extracranial)

Interventions

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).

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Joana M Mack, MD · University of Arkansas for Medical Sciences, Arkansas Children's Hospital

  • Kevin J Bielamowicz, MD, · University of Arkansas for Medical Sciences, Arkansas Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2025-09-03
Completion
2025-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125471 on ClinicalTrials.gov