Concomitant Oral and Intravenous Pharmacokinetics of Dabrafenib, a BRAF Inhibitor, in Patients with BRAF V600 Mutation-Positive Solid Tumors

Author:

Denton Cathrine L.1,Minthorn Elisabeth2,Carson Stanley W.1,Young Graeme C.3,Richards-Peterson Lauren E.4,Botbyl Jeffrey5,Han Chao6,Morrison Royce A.7,Blackman Samuel C.8,Ouellet Daniele1

Affiliation:

1. GlaxoSmithKline; Research Triangle Park NC USA

2. GlaxoSmithKline; Collegeville PA USA

3. GlaxoSmithKline; Ware UK

4. GlaxoSmithKline; King of Prussia PA USA

5. Provonix; Mullica Hill NJ USA

6. Biologics Clinical Pharmacology; Janssen R&D; Spring House PA USA

7. Comprehensive Clinical Development; Tacoma WA USA

8. Translational Medicine; Seattle Genetics, Inc.; Bothell WA USA

Funder

GlaxoSmithKline

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference14 articles.

1. Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial;Falchook;Lancet.,2012

2. Dabrafenib in BRAF-mutated metastatic melanoma: A multicentre, open-label, phase 3 randomised controlled trial;Hauschild;Lancet.,2012

3. BREAK-2: a phase IIA trial of the selective BRAF kinase inhibitor GSK2118436 in patients with BRAF mutation-positive (V600E/K) metastatic melanoma;Trefzer;Pigment Cell Melanoma Res.,2011

4. Characterization of the absorption, distribution, metabolism and elimination of a single oral 14C labeled dose of dabrafenib in subjects with BRAF V600-mutation positive solid tumors;Nebot;Clin Pharmacol Ther.,2013

5. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf 2013

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