Full TitlePhase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advanced BRAF V600-Mutation Positive Solid Tumors
Dabrafenib is a new drug approved for treating patients with melanoma. It is also being assessed in patients with certain types of brain tumors and other tumors that contain a V600E mutation in a gene called BRAF. It is designed to inhibit cancer growth by blocking the activity of the BRAF protein, which is abnormal in some cancers.
The purpose of this study is to find the highest dose of dabrafenib that can be given safely in children with advanced solid tumors (particularly brain tumors) that contain the V600E BRAF mutation. Dabrafenib is a pill that is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- This study is open to patients who are at least age 1 year and younger than 18 years.
- Patients must have an advanced solid tumor that contains the V600E BRAF mutation and has continued to grow despite prior therapy. For patients with melanoma, no prior therapy is required.
- At least 3 weeks should have passed since prior chemotherapy or radiation therapy (4 weeks since any investigational treatments) and entry into the study.