Protocol

BRF116: Phase I/II a, 2-Part, Multi-Cancer, Single-Arm, Open-Label Study to determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Pediatric Subjects Aged 1 Month to < 18 Years with Advance BRAF V600-Mutation Positive Solid Tumors

Diseases

Solid Tumor : Solid tumors, giomas, hystiosytosis

Description

The purpose of the study is to test the safety of dabrafenib given at different doses and find out what effects; good or bad, dabrafenib has on children one year to 17 years old who have certain kinds of cancerous tumors (BRAF V600 mutation positive tumors), as well as to find out how much of the drug gets into the blood stream and how long the body takes to get rid of it.

The study has two parts. Each participant will take part in only one part of the study. In Part 1, dabrafenib will be given at different doses to see which dose is safest to give to children. In Part 2, the dose will be set depending on the results of Part 1. In Part 2, dabrafenib will be further tested for how safe, how well tolerated and how active it is.

Dabrafenib has been approved by the Food and Drug Administration (FDA) for doctors to prescribe to adult patients with metastatic melanoma. So far, over 1,000 adults and five children less than 18 years of age have received dabrafenib in other studies. Dabrafenib has not been approved by the FDA for use in children; therefore, the use of dabrafenib in this study is experimental.


Objectives (Primary and Secondary)


Eligibility criteria, among others, include:


Contact

Alberto Broniscer, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105 USA
Phone: (901) 595-2544 or (901) 595-4599
FAX: (901) 595-6211

Or

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: (901) 595-2544
FAX: (901) 595-6211

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.