Study of MEK162 for Children With Low-Grade Gliomas (NCT02285439) | Clinical Trial Compass
CompletedPhase 1/2
Study of MEK162 for Children With Low-Grade Gliomas
United States105 participantsStarted 2016-05-04
Plain-language summary
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.
Who can participate
Age range1 Year – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients with recurrent or progressive disease, as defined in the following three strata below, will be eligible. For eligibility determination, tumor imaging from at least two time-points must be available to document radiographic progression or recurrence. Patients with non-progressive refractory tumors will not be eligible.
* Stratum 1: patients with LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging.
* Stratum 2: patients with NF1 and LGG that is measurable in at least two dimensions on imaging.
* Stratum 3: Pediatric patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in strata 1 or 2 that is measurable in at least two dimensions on imaging. This includes any LGG not included in strata 1 or 2 (i.e., any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation.
* Stratum 4 (surgical arm, target validation): Patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated.
* Tumor tissue for correlative studies must be available for all patients except those with NF1 and LGG (stratum 2) or any patient with optic pathway glioma (stratum 2 or 3), for whom tumor tissue is optional.
* Patients must have received at least one prior chemotherapy or radiation regimen prior to progression.
* At the time of enro…
What they're measuring
1
Best Overall Response Rate (Strata 1 and 2)
Timeframe: 48 weeks
2
12 Cycle Progression-free and Overall Survival (Strata 1 and 2)