Observational Study Monitoring Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Advanced or Recurrent Solid Tumors

What this Trial Is About

This research observes patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer, to monitor the safety and effectiveness of dabrafenib and trametinib. It is a prospective, multicenter, single-arm, non-interventional observational study that collects real-world data under current medical practices. The study is conducted using an electronic data capture system and aims to gather long-term information especially in pediatric patients. Participants receive dabrafenib and trametinib as prescribed according to the Japanese Package Insert without treatment assignment by the study. Adult patients are observed for one year after starting treatment, while pediatric patients are followed for up to eight years regardless of whether they continue treatment, to collect extensive safety and response data during the reexamination period. The study aims to include approximately 65 adults and about 20 pediatric patients. During the study, researchers collect data on adverse events related to skeletal and sexual maturation in pediatric patients, overall response rate in adults, progression-free survival, changes in height and weight, and other safety outcomes. Data collection occurs throughout the observation periods for both adult and pediatric patients. The study is sponsored by Novartis Pharmaceuticals and is designed to provide important long-term safety and effectiveness information on these medications used in routine care.

Special Drug Use-results Surveillance of Tafinlar/Mekinist