Effects of food on the relative bioavailability of lapatinib in cancer patients

Journal of Clinical Oncology

Volumn 27, Issue 8, 2009, Pages 1191-1196

  Lewis, Lionel D ^a   Koch, Kevin M ^a   Reddy, Nandi J ^a   Cohen, Roger B ^a   Lewis, Nancy L ^a   Whitehead, Bonnie ^a   Mackay, Kathleen ^a   Stead, Andrew ^a   Beelen, Andrew P ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LAPATINIB;

ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; CANCER PATIENT; CHONDROSARCOMA; CLINICAL TRIAL; COLON CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEMOGRAPHY; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG HALF LIFE; DRUG SAFETY; FATIGUE; FEMALE; FOLLICULAR LYMPHOMA; FOOD; FOOD DRUG INTERACTION; HEAD AND NECK CANCER; HUMAN; KARNOFSKY PERFORMANCE STATUS; KIDNEY CANCER; LIPID DIET; LIVER CANCER; LOW FAT DIET; LUNG CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MELANOMA; NAUSEA; OPEN STUDY; OVARY ADENOCARCINOMA; PANCREAS CANCER; PAROTID GLAND CANCER; PRIORITY JOURNAL; PROSTATE CANCER; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; SOLID TUMOR; STATISTICAL ANALYSIS; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; QUINAZOLINES; SOLUBILITY;

EID: 62449338902     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.18.3285     Document Type: Article

References (24)

1. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
2. Slamon DJ, Clark GM, WongSG, et al: Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235:177-182, 1987
3. Burris HA, Hurwitz HI, Dees EC, et al: Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas. J Clin Oncol 23:5305-5313, 2005
4. Polli JW, Humphreys JE, Harmon KA, et al: The role of efflux and uptake transporters in [N-(3-chloro- 4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2- (methylsulfonyl) ethyl]amino}methyl)-2-furyl]-4-quinazolinamine) (GW572016, lapatinib) disposition and drug interactions. Drug Metab Dispos 36:695-701, 2008
5. Smith DA, Koch KM, Lee D, et al: The effect of food on the pharmacokinetics of GW572016. Eur J Cancer 1 :S169, 2003 (suppl; abstr 558)
6. Hsieh S, Tobien T, Koch K, et al: Increasing throughput of parallel on-line extraction liquid chromatography/electrospray ionization tandem mass spectrometry system for GLP quantitative bioanalysis in drug development. Rapid Commun Mass Spectrom 18:285-292, 2004
7. Jones HM, Parrott N, Ohlenbusch G, et al: Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modelling. Clin Pharmacokinet45:1213-1226, 2006
8. Singh BN, Malhotra BK: Effects of food on the clinical pharmacokinetics of anticancer agents: Underlying mechanisms and implications for oral chemotherapy. Clin Pharmacokinet 43:1127-1156, 2004
9. Dressman J: Comparison of canine and human gastrointestinal physiology. Pharm Res 3:123- 131, 1986
10. Hunt JN, Stubbs DF: The volume and energy content of meals as determinants of gastric emptying. J Physiol 245:209-225, 1975
11. Calbet JA, MacLean DA: Role of caloric content on gastric emptying in humans. J Physiol 498: 553-559, 1997
12. Charman WN, Porter CJH, Mithanai S, et al: Physicochemical and physiological mechanisms for the effects of food on drug absorption: The role of lipids and pH. J Pharm Sci 86:269-282, 1997
13. Sievanen E: Exploitation of bile acid transport systems in prodrug design. Molecules 12:1859- 1889, 2007
14. DeSesso JM, Jacobson CF: Anatomical and physiological parameters affecting gastrointestinal absorption in humans and rats. Food Chem Toxicol 39:209-228, 2001
15. Bakatselou V, Oppenheim RC, Dressman JB: Solubilization and wetting effects of bile salts on the dissolution of steroids. Pharm Res 8:1461-1469, 1991
16. Johnson JR, Cohen M, Rajeshwari S, et al: Approval summary for erlotinib for treatment of patients with locally advanced or metastatic small- cell lung cancer after failure of at least one prior chemotherapy regimen. Clin Cancer Res 11:6414- 6421, 2005
17. Swaisland HC, Smith RP, Laight A: Single- dose clinical pharmacokinetic studies of gefitinib. Clin Pharmacokinet 44:1165-1177, 2005
18. Dasatinib Package Insert. http//:www.sprycel.com, revised November 2008
19. Lange H, Eggers R, Bircher J: Increased systemic availability of albendazole when taken with a fatty meal. Eur J Clin Pharmacol 34:315-317, 1988
20. Castro N, Medina R, Sotelo J, et al: Bioavailability of praziquantel increases with concomitant administration of food. Antimicrob Agents Chemother 44:2903-2904, 2000
21. Rolan PE, Mercer AJ, Weatherley BC, et al: Investigation of the factors responsible for a food- induced increase in absorption of a novel antiprotozoal drug 566C80. Br J Clin Pharmacol 33:534P- 535P, 1992
22. Doose DR, Minn FL, Stellar S, et al: Effects of meals and meal composition on the bioavailability of fenretinide. J Clin Pharmacol 32:1089-1095, 1992
23. Reigner B, Verweij J, Dirix L, et al: Effect of food on the pharmacokinetics of capecitabine and its metabolites following oral administration in cancer patients. Clin Cancer Res 4:941-948, 1998
24. Spector NL, Yarden Y, Smith B, et al: Activation of AMP-activated protein kinase by human EGF receptor 2/EGF receptor tyrosine kinase inhibitor protects cadiac cells. Proc Natl Acad Sci U S A 104:10607- 10612, 2007