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MEK162 for Low-Grade Glioma in Children
Study Summary
This trial is a Phase I/II study to test the safety and effectiveness of the drug MEK162 in children and adolescents with tumors.
- Low Grade Glioma
- Soft Tissue Tumors
- Brain Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 402 Patients • NCT01763164Trial Design
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- You have ongoing stomach or intestinal problems like ulcers, severe nausea, vomiting, or diarrhea.You have other treatment options available that can cure or manage your condition with acceptable side effects.You have a history of Gilbert's syndrome.You have previously been treated with a MEK inhibitor.You have a history of retinal vein occlusion or conditions that increase the risk of developing it, like uncontrolled glaucoma or blood clotting disorders.You are currently taking any other cancer medication or experimental treatment.You have used certain medications to boost your blood cells in the last two weeks.You have a disease that has come back or gotten worse, as confirmed by medical imaging.We need a sample of your tumor for research, except if you have a specific condition called NF1 and LGG, or if you have a type of brain tumor called optic pathway glioma.You have received at least one round of chemotherapy or radiation before your condition got worse.You must be older than 1 year and younger than 18 years.Your organs and bone marrow must be working normally within two weeks before joining the study.You have a muscle or nerve disorder that causes high levels of CK in your blood.You have high blood pressure that is not being managed well.You have a history of a certain eye disease that causes vision loss.
- Group 1: Target Validation
- Group 2: Phase 1
- Group 3: Phase 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities to participate in this clinical experiment?
"Clinicaltrials.gov has recorded that this trial, which was initially posted on April 1st 2016 and last updated February 28th 2022, is no longer recruiting patients. Nevertheless, over three thousand other clinical trials are currently looking for participants."
How many venues is this investigation taking place in?
"Currently, Seattle Children's Hospital in Washington State, the Children’s National Heath Systems located in the District of Columbia, and Nicklaus Children's Hospital situated in Florida are all sites that accept participants for this medical trial. Additionally, there are 15 other study centres with similar eligibility requirements."
Can you discuss any additional investigations that have been conducted involving MEK162?
"MEK162 was initially studied in 2011 at LMU Klinikum der Universität, with 24 clinical trials now concluded. Currently, there are 59 studies underway, many of which originate from Seattle, Washington."
How many participants are contributing to this research?
"Unfortunately, this trial has already concluded its patient recruitment. It was initially listed on April 1st 2016 and had its final update on February 28th 2022. Nevertheless, there are still 2979 studies related to soft tissue neoplasms in need of participants as well as 59 trials involving MEK162 that require volunteers."
Do I possess the necessary qualifications to participate in this experiment?
"To be eligible, subjects must possess soft tissue neoplasms and lie between the ages of 1 Year and 18. Thus far, 105 individuals have been accepted into this medical trial."
Is this trial a pioneering endeavor?
"First tested in 2011, MEK162 has a long history of clinical trials. Pfizer sponsored the initial trial, which included 183 patients and ended with Phase 2 approval. Today there are 59 active studies for MEK162 taking place all over the world within 1120 cities across 39 distinct countries."
Is the minimum age requirement of this experiment higher than 25?
"This clinical trial has a narrow age range, as only those between 1 Year and 18 Years are eligible to participate. In comparison, there exist 445 studies for patients under the legal age of adulthood and 2736 investigations applicable to elderly individuals above 65 years old."
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