A Phase I and Pharmacokinetic Study of Oral Dabrafenib in Children and Adolescent Patients with Recurrent or Refractory BRAF V600 Mutation–Positive Solid …

MW Kieran, B Geoerger, IJ Dunkel, A Broniscer… - Clinical Cancer …, 2019 - AACR
Abstract Purpose: The 2-part, phase I/IIa, open-label study (NCT01677741) sought to
determine the safety, tolerability, pharmacokinetics, and preliminary activity of dabrafenib in …

Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation–Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study

DR Hargrave, E Bouffet, U Tabori, A Broniscer… - Clinical Cancer …, 2019 - AACR
Purpose: Pediatric low-grade glioma (pLGG) is the most prevalent childhood brain tumor.
Patients with BRAF V600 mutation–positive pLGG may benefit from treatment with …

Phase 1 study of dabrafenib in pediatric patients (pts) with relapsed or refractory BRAF V600E high- and low-grade gliomas (HGG, LGG), Langerhans cell …

MW Kieran, DR Hargrave, KJ Cohen, I Aerts, IJ Dunkel… - 2015 - ascopubs.org
10004 Background: Dabrafenib is an orally available, selective ATP-competitive inhibitor of
BRAF V600E kinase, approved in unresectable or metastatic melanoma pts with the V600E …

Expanding the Benefit: Dabrafenib/Trametinib as Tissue-Agnostic Therapy for BRAF V600E–Positive Adult and Pediatric Solid Tumors

MA Gouda, V Subbiah - American Society of Clinical Oncology …, 2023 - ascopubs.org
The recent US Food and Drug Administration (FDA) approval of the dabrafenib/trametinib
combination as a tissue-agnostic treatment for solid tumors with BRAF V600E mutation is the …

Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H

AKS Salama, S Li, ER Macrae, JI Park… - Journal of Clinical …, 2020 - ascopubs.org
PURPOSE BRAFV600 mutations are commonly found in melanoma and thyroid cancers
and to a lesser degree in other tumor types. Subprotocol H (EAY131-H) of the NCI-MATCH …

Dose selection, pharmacokinetics, and pharmacodynamics of BRAF inhibitor dabrafenib (GSK2118436)

GS Falchook, GV Long, R Kurzrock, KB Kim… - Clinical Cancer …, 2014 - AACR
Purpose: Dabrafenib is a selective, potent ATP-competitive inhibitor of the BRAF V600-
mutant kinase that has demonstrated efficacy in clinical trials. We report the rationale for …

[HTML][HTML] Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial

V Subbiah, RJ Kreitman, ZA Wainberg, A Gazzah… - Nature medicine, 2023 - nature.com
BRAFV600E alterations are prevalent across multiple tumors. Here we present final efficacy
and safety results of a phase 2 basket trial of dabrafenib (BRAF kinase inhibitor) plus …

Concomitant oral and intravenous pharmacokinetics of dabrafenib, a BRAF inhibitor, in patients with BRAF V600 mutation‐positive solid tumors

CL Denton, E Minthorn, SW Carson… - The Journal of …, 2013 - Wiley Online Library
Dabrafenib is an orally bioavailable, potent, and selective inhibitor of human wild‐type
BRAF and CRAF kinases as well as mutant forms of BRAF kinase. The aim of this phase 1 …

Rapid clinical and radiographic response with combined dabrafenib and trametinib in adults with BRAF-mutated high-grade glioma

TM Johanns, CJ Ferguson, PM Grierson… - Journal of the National …, 2018 - jnccn.org
BRAF V600E mutations have been successfully treated with targeted therapy in melanoma,
non–small cell lung cancer, and thyroid cancer. Interestingly, these mutations have also …

Dabrafenib: first global approval

AD Ballantyne, KP Garnock-Jones - Drugs, 2013 - Springer
Dabrafenib (Tafinlar®), a mutant-BRAF kinase inhibitor, emerged from GlaxoSmithKline's
research programme for the discovery of selective inhibitors of mutant BRAF kinase activity …