Absolute Bioavailability of Vemurafenib in Patients With BRAF
bioavailability
melanoma
pharmacokinetics
vemurafenib
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
14
06
2019
accepted:
16
12
2019
pubmed:
23
2
2020
medline:
6
5
2022
entrez:
22
2
2020
Statut:
ppublish
Résumé
Vemurafenib is a BRAF kinase inhibitor indicated for the treatment of patients with BRAF
Substances chimiques
Protein Kinase Inhibitors
0
Vemurafenib
207SMY3FQT
BRAF protein, human
EC 2.7.11.1
Proto-Oncogene Proteins B-raf
EC 2.7.11.1
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
496-504Subventions
Organisme : F. Hoffmann-La Roche, Ltd.
Informations de copyright
© 2020, The American College of Clinical Pharmacology.
Références
Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507-2516.
McArthur GA, Chapman PB, Robert C, et al. Safety and efficacy of vemurafenib in BRAFV600E and BRAFV600K mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014;15(3):323-332.
Diamond EL, Subbiah V, Lockhart AC, et al. Vemurafenib for BRAF V600-mutant Erdheim-Chester disease and Langerhans cell histiocytosis: analysis of data from the histology-independent, phase 2, open-label VE-BASKET study. JAMA Oncol. 2018;4(3):384-388.
Larkin J, Ascierto PA, Dreno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371(20):1867-1876.
Ascierto PA, McArthur GA, Dreno B, et al. Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016;17(9):1248-1260.
Zhang W, McIntyre C, Forbes H, et al. Effect of rifampicin on the pharmacokinetics of a single dose of vemurafenib in patients with BRAFV600 mutation-positive metastatic malignancy. Clinical Pharmacol Drug Dev. 2019;8(6):837-843.
Zhang W, McIntyre C, Kuhn M, et al. Effect of vemurafenib on the pharmacokinetics of a single dose of digoxin in patients with BRAFV600 mutation-positive metastatic malignancy. J Clin Pharmacol. 2018;58(8):1067-1073.
Grippo JF, Zhang W, Heinzmann D, et al. A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of vemurafenib in patients with BRAFV600E mutation-positive metastatic melanoma. Cancer Chemother Pharmacol. 2014;73(1):103-111.
Ribas A, Zhang W, Chang I, et al. The effects of a high-fat meal on single-dose vemurafenib pharmacokinetics. J Clin Pharmacol. 2014;54(4):368-374.
Zhang W, Heinzmann D, Grippo JF. Clinical pharmacokinetics of vemurafenib. Clin Pharmacokinet. 2017;56(9):1033-1043.
Goldinger SM, Rinderknecht J, Dummer R, et al. A single-dose mass balance and metabolite-profiling study of vemurafenib in patients with metastatic melanoma. Pharmacol Res Perspect. 2015;3(2):e00113.
Shah N, Iyer RM, Mair HJ, et al. Improved human bioavailability of vemurafenib, a practically insoluble drug, using an amorphous polymer-stabilized solid dispersion prepared by a solvent-controlled coprecipitation process. J Pharm Sci. 2013;102(3):967-981.
Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. 2010;363(9):809-819.
Boulton DW, Kasichayanula S, Keung CFA, et al. Simultaneous oral therapeutic and intravenous 14C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Br J Clin Pharmacol. 2013;75(3):763-768.
Williams HD, Trevaskis NL, Charman SA, et al. Strategies to address low drug solubility in discovery and development. Pharmacol Rev. 2013;65(1):315-499.
Sarapa N, Hsyu PH, Lappin G, Garner RC. The application of accelerator mass spectrometry to absolute bioavailability studies in humans: simultaneous administration of an intravenous microdose of 14C-nelfinavir mesylate solution and oral nelfinavir to healthy volunteers. J Clin Pharmacol. 2005;45(10):1198-1205.
Kishore RS, Kiese S, Fischer S, Pappenberger A, Grauschopf U, Mahler HC. The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics. Pharm Res. 2011;28(5):1194-1210.
Swart P, Lozac'h F, Simon M, van Duijn E, Vaes WH. The impact of early human data on clinical development: there is time to win. Drug Discov Today. 2016;21(6):873-879.
Steele RH, Limaye S, Cleland B, Chow J, Suranyi MG. Hypersensitivity reactions to the polysorbate contained in recombinant erythropoietin and darbepoietin. Nephrology. 2005;10(3):317-320.
Schwartzberg LS, Navari RM. Safety of polysorbate 80 in the oncology setting. Adv Ther. 2018;35(6):754-767.
Coors EA, Seybold H, Merk HF, Mahler V. Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol. 2005;95(6): 593-599.