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Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study) | Clinical Trials | Clareo Health

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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)

NCT05125471•University of Arkansas

View on ClinicalTrials.gov

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).

Eligibility

Age

2 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2 years to 80 years of age
•Extracranial AVM with volumetric measurable disease AVM Tissue from a prior biopsy along with the corresponding pathology report will be required. If not available, a biopsy will be performed per standard of care
•Patient must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric or gastric tube
•Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50% for patients ≤ 16 years of age
•ANC ≥ 0.75 x 109/L (unsupported/without growth factor stimulant in past 7 days) Platelet count ≥ 75 x 109/L (unsupported/without transfusion in past 7 days) Hemoglobin ≥ 8 g/dL (unsupported/without transfusion in past 7 days)
•Calculated creatinine clearance (or radioisotope GFR) ≥ 70 mL/min/1.73m2 or serum creatinine based on age/gender as follows:
•* Age 2 \< 6 years: Male 0.8; Female 0.8
•* Age 6 to \< 10 years: Male1; Female 1
•* Age 10 to \< 13 years: Male 1.2; Female 1.2
•* Age 13 to \< 16 years: Male 1.5; Female 1.4
+6 more criteria

Exclusion Criteria

•Patients taking strong inducers or inhibitors of CYP3A4 within 14 days prior to study entry, including but not limited to erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice, or St. John's Wort. Appendix A includes a list of other known CYP3A4 inducers and inhibitors that should be discontinued at least 14 days prior to initiation of cobimetinib and avoided during study participation, if reasonable alternatives exist
•Completion of previous chemotherapy, immunotherapy, or targeted therapy for extracranial AVM with resolution of all associated toxicity to ≤ Grade 1 (except for alopecia and ototoxicity, which do not need to be resolved ≤ Grade 1) at least 28 days prior to study entry (except if otherwise specified below). Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to study entry. If, after the required timeframe, the laboratory eligibility criteria are met, the patient is considered to have recovered adequately
•Treatment with a long-acting hematopoietic growth factor within 14 days prior to initiation of cobimetinib or a short-acting hematopoietic growth factor within 7 days prior to study entry
•Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives), immunotherapy, biologic therapy, investigational therapy, or herbal cancer therapy within 28 days or \< 5 half-lives, whichever is longer, prior to study entry
•Corticosteroid therapy \< 0.5 mg/kg/day averaged during the month prior to study entry is permissible but must be discontinued 14 days prior to study entry
•Active malignancy or history of secondary malignancy
•History of severe hypersensitivity reactions to components of cobimetinib
•Refractory nausea and vomiting, malabsorption, external biliary shunt
•Patients who have a known active infection (excluding documented fungal infection of the nail beds) within 28 days prior to study entry that has not completely resolved
•Major surgical procedure or significant traumatic injury within 28 days prior to study entry, or anticipation of the need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within 14 days of study entry (provided the wound has healed)
+11 more criteria

Locations (1)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Key Dates

Start Date

July 26, 2022

Primary Completion Date

September 3, 2025

Completion Date

September 3, 2025

Last Updated

September 10, 2025

Enrollment

ACTUAL participants

Conditions

Arteriovenous Malformations (Extracranial)

Interventions

Cobimetinib

DRUG