Pharmacokinetic and tolerability profile of once-daily zibotentan (ZD4054) in Japanese and Caucasian patients with hormone-resistant prostate cancer

International Journal of Clinical Pharmacology and Therapeutics

Volumn 48, Issue 11, 2010, Pages 708-717

  Ranson, M ^a   Wilson, R H ^b   O'Sullivan, J M ^b   Maruoka, M ^c   Yamaguchi, A ^d   Cowan, R A ^a   Logue, J P ^a   Tomkinson, H ^e   Tominaga, N ^e   Swaisland, H ^e   Oliver, S ^e   Usami, M ^f  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^c CHIBA CANCER CENTER   (Japan)

^d HARASANSHIN HOSPITAL   (Japan)

^e ASTRAZENECA   (United Kingdom)

^f OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

Author keywords

Caucasian; Japanese; Pharmacokinetics; Prostate cancer; Zibotentan

Indexed keywords

N (3 METHOXY 5 METHYL 2 PYRAZINYL) 2 [4 (1,3,4 OXADIAZOL 2 YL)PHENYL] 3 PYRIDINESULFONAMIDE;

ABNORMAL SENSATION; ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BODY WEIGHT; CAUCASIAN; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DISTRIBUTION VOLUME; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; ETHNIC DIFFERENCE; FATIGUE; GASTRITIS; HEART PALPITATION; HORMONE RESISTANT PROSTATE CANCER; HUMAN; JAPANESE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE DRUG DOSE; MUSCULOSKELETAL STIFFNESS; MYALGIA; NAUSEA; NOSE CONGESTION; OPEN STUDY; PERIPHERAL EDEMA; POLLAKISURIA; PROSTATE CANCER; SIDE EFFECT; SINGLE DRUG DOSE; THIRST; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

EID: 78649239184     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP48708     Document Type: Article

References (22)

1. Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol. 2006; 24: 2137-2150. (Pubitemid 46655601)
2. Ewis AA, Lee J, Naroda T et al. Prostate cancer incidence varies among males from different Y-chromosome lineages. Prostate Cancer Prostatic Dis. 2006; 9: 303-309.
3. Kim K, Johnson JA, Derendorf H. Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms. J Clin Pharmacol. 2004; 44: 1083-1105.
4. Ingelman-Sundberg M. Pharmacogenetics: an opportunity for a safer and more efficient pharmacotherapy. J Intern Med. 2001; 250: 186-200. (Pubitemid 34205685)
5. Sata F, Umemura T, Kishi R. The epidemiology of prostate cancer - recent trends in prostate cancer incidence and mortality. Gan To Kagaku Ryoho. 2001; 28: 184-188.
6. Carter BS, Beaty TH, Steinberg GD, Childs B, Walsh PC. Mendelian inheritance of familial prostate cancer. Proc Natl Acad Sci USA. 1992; 89: 3367-3371.
7. Gronberg H. Prostate cancer epidemiology. Lancet. 2003; 361: 859-864.
8. Ingelman-Sundberg M, Oscarson M, McLellan RA. Polymorphichuman cytochrome P450 enzymes: an opportunity for individualized drug treatment. Trends Pharmacol Sci. 1999; 20: 342-349. (Pubitemid 29366813)
9. Nebert DW, Dieter MZ. The evolution of drug metabolism. Pharmacology. 2000; 61: 124-135.
10. Wolf CR, Smith G, Smith RL. Science, medicine, and the future: Pharmacogenetics. BMJ. 2000; 320: 987-990.
11. Ma MK, Woo MH, McLeod HL. Genetic basis of drug metabolism. Am J Health Syst Pharm. 2002; 59: 2061-2069.
12. Weinshilboum R. Inheritance and drug response. N Engl J Med. 2003; 348: 529-537.
13. Bagnato A, Natali PG. Endothelin receptors as novel targets in tumor therapy. J Transl Med. 2004; 2: 16.
14. Herrmann E, Bogemann M, Bierer S, Eltze E, Hertle L, Wulfing C. The endothelin axis in urologic tumors: mechanisms of tumor biology and therapeutic implications. Expert Rev Anticancer Ther. 2006; 6: 73-81.
15. Nelson J, Bagnato A, Battistini B, Nisen P. The endothelin axis: emerging role in cancer. Nat Rev Cancer. 2003; 3: 110-116.
16. Carducci MA, Jimeno A. Targeting bone metastasis in prostate cancer with endothelin receptor antagonists. Clin Cancer Res. 2006; 12: 6296S-6300S.
17. Okazawa M, Shiraki T, Ninomiya H, Kobayashi S, Masaki T. Endothelin-induced apoptosis of A375 human melanoma cells. J Biol Chem. 1998; 273: 12584-12592. (Pubitemid 28240635)
18. James ND, Caty A, Borre M et al. Safety and efficacy of the specific endothelin Areceptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomized, Phase II trial. Eur Urol. 2009; 55: 1112-1123.
19. Carducci MA, Nelson JB, Bowling MK et al. Atrasentan, an endothelin-receptor antagonist for refractory adenocarcinomas: safety and pharmacokinetics. J Clin Oncol. 2002; 20: 2171-2180.
20. Clarkson-Jones J, Kenyon A, Kemp J et al. Metabolism of [14C]-ZD4054 in healthy volunteers. Eur J Cancer. 2007; 5 (Suppl 4): 114.
21. Swaisland HC, Oliver SD, Morris T et al. In vitro metabolism of the specific endothelin-A receptor antagonist ZD4054 and clinical drug interactions between ZD4054 and rifampicin or itraconazole in healthy male volunteers. Xenobiotica. 2009; 39: 444-456.
22. Xie HG, Kim RB, Wood AJ, Stein CM. Molecular basis of ethnic differences in drug disposition and response. Annu Rev Pharmacol Toxicol. 2001; 41: 815-850.