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Dabrafenib + Trametinib for Brain Tumors
Study Summary
This trial is continuing to assess the long-term effects of the drugs dabrafenib and trametinib in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 12 Patients • NCT01928940Trial Design
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Who is running the clinical trial?
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- I am willing and able to follow the study's schedule and procedures.My medication (dabrafenib/trametinib) is approved and paid for in my country.I am currently in a Novartis study using dabrafenib/trametinib for my treatment.I have participated in a Novartis study like CTMT212X2101.I have been part of a study where I received dabrafenib and/or trametinib with another drug.I had severe side effects from dabrafenib/trametinib, stopping my treatment.The doctor thinks you will benefit from staying in the study and receiving treatment.
- Group 1: Dabrafenib and/or trametinib
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is there still availability for patients to join this clinical trial?
"That is correct. According to the information posted on clinicaltrials.gov, this research project was initially published on November 4th 2019 and has been recently updated as of September 30th 2022. The trial requires 250 participants spread across 10 independent sites for enrolment."
Are there prior experiments that have included dabrafenib as a factor?
"At present, 95 different clinical trials are assessing the efficacy of dabrafenib. Of those active studies, 6 have advanced to Phase 3. Though Honolulu is hosting a considerable number of these investigations, there are 5805 other sites across the world participating in this research."
Has dabrafenib been officially sanctioned by the FDA?
"There is an abundance of data that attest to the safety of dabrafenib, so it has been rated a 3 on our scale. This treatment is currently approved for use in medical settings."
How many individuals have enrolled in this clinical experiment?
"This clinical trial necessitates the recruitment of 250 qualified participants. There are two primary enrolment sites, Children's National Hospital CQTI571A2306 in Washington D.C., and Cincinnati Children’s Hospital Medical Center in Ohio."
How many geographical sites are participating in the trial?
"At present, 10 sites situated in Washington, Cincinnati, Phoenix and other cities are enrolling participants for the trial. To reduce travel burdens associated with enrollment, it is wise to select a situate close by."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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