Study of MEK162 for Children With Low-Grade Gliomas

Completed · Phase 1/Phase 2

Conditions studied: Low-Grade Gliomas, Malignant Neoplasms, Brain, Soft Tissue Neoplasms

In brief

The goal of this clinical trial is to study the drug MEK162 in children with a brain tumor call low-grade glioma, as well as in children with other tumors in which a specific growth signal is abnormally turned on. The main questions it aims to answer are: What is the correct dose of MEK162 in children? What are the side effects of MEK162 in children? Is MEK162 effective in children with low-grade glioma? Participants on the study receive MEK162 by mouth twice daily for up to 2 years.

Key facts

Study ID

NCT02285439

Run by

Children's Hospital Los Angeles

People needed

105

Starts

2016-05-04

Expected to finish

2025-08-01

Last updated by the study team

2025-10-07

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with any of the following characteristics will not be eligible:
• Patients for whom other curative or established standard-of-care therapeutic options with acceptable morbidity exist.
• Patients with any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
• History of Gilbert's syndrome
• Patients receiving any other anticancer or experimental drug therapy.
• Use of hematopoietic growth factors within 2 weeks prior to initiation of therapy.
• Any other investigational agents within 2 weeks or ≤ 3 half-lives (whichever is longer) before start of study therapy.
• Patients who have undergone surgery ≤ 3 weeks or who have not recovered from side effects of this procedure prior to receiving study drug.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, impaired gastrointestinal function, or psychiatric illness/social situations that would limit compliance with study requirements.
• History or current evidence of retinal vein occlusion (RVO) or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
• History of retinal degenerative disease
• Prior therapy with a MEK inhibitor
• Impairment of gastrointestinal function (e.g., active ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
• Patients who have a neuromuscular disorder that is associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
• Patients with uncontrolled hypertension
• Inclusion of Women, Minorities, and Other Underrepresented Populations This protocol is open to males and females of all races. See Inclusion Criteria above regarding specific eligibility requirements for female and male patients of child-bearing or child-fathering potential, respectively.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Children's National Heath Systems — Washington D.C., District of Columbia, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Hospitals and Clinics of Minnesota-Minneapolis — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York University — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Texas Southwestern Medical — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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