This research study is studying a drug TAK-580 (MLN2480) as a possible treatment a low-grade
glioma that has not responded to other treatments.
The name of the study drug involved in this study is:
This is a Phase I clinical trial. A Phase I clinical trial tests the safety of an
investigational drug and also tries to define the appropriate dose of the investigational
drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved TAK-580 as a treatment for any
This is the first time that TAK-580 will be given to children. There is limited experience
with TAK-580 in humans.
The purpose of this study is to test the safety TAK-580 in children and adolescent
participants with brain tumors. The investigators want to find out what effects, good and/or
bad, it has on participants and the participant's brain tumor, and find the dose of TAK-580
that is tolerated by participants without too many side effects to use in Phase II of the
Research in the laboratory has shown that TAK-580 may have activity against cancer cells.
TAK-580 belongs to a group of drugs called type II BRAF inhibitors. BRAF abnormalities are
found in cancer cells. There are no type II BRAF inhibitors approved by the FDA for humans at
the time of this study's start. TAK-580 functions by binding the mutant BRAF molecule and
causing a conformation change in the molecule thereby blocking the signal that tells the
tumor cell to divide.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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