A clinical drug–drug interaction study to evaluate the effect of a proton-pump inhibitor, a combined P-glycoprotein/cytochrome 450 enzyme (CYP)3A4 inhibitor, and a CYP2C9 inhibitor on the pharmacokinetics of vismodegib

Author:

Malhi Vikram,Colburn Dawn,Williams Sarah J.,Hop Cornelis E. C. A.,Dresser Mark J.,Chandra Priya,Graham Richard A.

Funder

F. Hoffmann-La Roche, Ltd.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Cancer Research,Pharmacology,Toxicology,Oncology

Reference16 articles.

1. Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A (2012) Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 366:2171–2179

2. Ding X, Chou B, Graham RA, Cheeti S, Percey S, Matassa LC, Reuschel SA, Meng M, Liu S, Voelker T, Lum BL, Rudewicz PJ, Hop CE (2010) Determination of GDC-0449, a small-molecule inhibitor of the Hedgehog signaling pathway, in human plasma by solid phase extraction–liquid chromatographic–tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 878:785–790

3. Graham RA, Hop CECA, Borin MT, Lum BL, Colburn D, Chang I, Shin YG, Malhi V, Low JA, Dresser MJ (2012) Single and multiple dose intravenous and oral pharmacokinetics of the hedgehog pathway inhibitor vismodegib in healthy female subjects. Br J Clin Pharmacol 74:788–796

4. LoRusso PM, Rudin CM, Reddy JC, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Chang I, Darbonne WC, Graham RA, Zerivitz KL, Low JA, Von Hoff DD (2011) Phase 1 trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res 17:2502–2511

5. Giannetti AM, Wong H, Dijkgraaf GJP, Dueber EC, Ortwine DF, Bravo BJ, Gould SE, Plise EG, Lum BL, Malhi V, Graham RA (2011) Identification, characterization, and implications of species-dependent plasma protein binding for the oral Hedgehog pathway inhibitor vismodegib (GDC-0449). J Med Chem 54:2592–2601

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