Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: Two open-label comparative studies

BMC Clinical Pharmacology

Volumn 11, Issue , 2011, Pages

  Tomkinson, Helen ^a   Kemp, John ^a   Oliver, Stuart ^a   Swaisland, Helen ^a   Taboada, Maria ^a   Morris, Thomas ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; BILIRUBIN; CREATININE; PARACETAMOL; ZIBOTENTAN; PYRROLIDINE DERIVATIVE;

ADULT; AGED; ALBUMIN BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; CREATININE CLEARANCE; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG FATALITY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG URINE LEVEL; DYSPEPSIA; FATIGUE; FEMALE; HEADACHE; HUMAN; KIDNEY FAILURE; LIVER FAILURE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; NECK PAIN; OPEN STUDY; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PROTHROMBIN TIME; QT PROLONGATION; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; SYSTOLIC BLOOD PRESSURE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; BLOOD; CLINICAL TRIAL; KIDNEY; LIVER; LIVER DISEASE; METABOLISM; MIDDLE AGED; ORAL DRUG ADMINISTRATION; URINE;

ADMINISTRATION, ORAL; AREA UNDER CURVE; CREATININE; FEMALE; HUMANS; KIDNEY; LIVER; LIVER DISEASES; MALE; MIDDLE AGED; PYRROLIDINES; RENAL INSUFFICIENCY;

EID: 79952704633     PISSN: None     EISSN: 14726904     Source Type: Journal    
DOI: 10.1186/1472-6904-11-3     Document Type: Article

References (32)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer Statistics, 2010. CA Cancer J Clin 2010, 60:277-300. 10.3322/caac.20073, 20610543.
2. Di Lorenzo G, Buonerba C, Autorino R, De Placido S, Sternberg CN. Castration-resistant prostate cancer: current and emerging treatment strategies. Drugs 2010, 70:983-1000. 10.2165/10898600-000000000-00000, 20481655.
3. Nelson JB. Endothelin inhibition: novel therapy for prostate cancer. J Urol 2003, 170:S65-S68. 10.1097/01.ju.0000096372.07687.86, 14610413.
4. 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. 10.1074/jbc.273.20.12584, 9575219.
5. Fukuroda T, Fujikawa T, Ozaki S, Ishikawa K, Yano M, Nishikibe M. Clearance of circulating endothelin-1 by ETB receptors in rats. Biochem Biophys Res Commun 1994, 199:1461-1465. 10.1006/bbrc.1994.1395, 8147891.
6. Nelson JB, Hedican SP, George DJ, Reddi AH, Piantadosi S, Eisenberger MA, Simons JW. Identification of endothelin-1 in the pathophysiology of metastatic adenocarcinoma of the prostate. Nat Med 1995, 1:944-949. 10.1038/nm0995-944, 7585222.
7. Nelson JB. Endothelin receptors as therapeutic targets in castration-resistant prostate cancer. Eur Urol Suppl 2009, 8:20-28.
8. Bagnato A, Natali PG. Endothelin receptors as novel targets in tumor therapy. J Transl Med 2004, 2:16. 10.1186/1479-5876-2-16, 436068, 15165288.
9. Smollich M, Wülfing P. Targeting the endothelin system: novel therapeutic options in gynecological, urological and breast cancers. Expert Rev Anticancer Ther 2008, 8:1481-1493. 10.1586/14737140.8.9.1481, 18759699.
10. James ND, Caty A, Payne H, Borre M, Zonnenberg BA, Beuzeboc P, McIntosh S, Morris T, De Phung H, Dawson NA. Final safety and efficacy analysis of the specific endothelin A receptor antagonist zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic for pain: A double-blind, placebo-controlled, randomised Phase II trial. BJU Int 2010, 106:966-973. 10.1111/j.1464-410X.2010.09638.x, 20840318.
11. Fizazi K, Miller K. Specific endothelin-A receptor antagonism for the treatment of advanced prostate cancer. BJU Int 2009, 104:1423-1425. 10.1111/j.1464-410X.2009.08740.x, 19624592.
12. Fizazi K, Sternberg CN, Fitzpatrick JM, Watson RW, Tabesh M. Role of targeted therapy in the treatment of advanced prostate cancer. BJU Int 2010, 105:748-767. 10.1111/j.1464-410X.2010.09236.x, 20353536.
13. Rosano L, Di Castro V, Spinella F, Decandia S, Natali PG, Bagnato A. ZD4054, a potent endothelin receptor A antagonist, inhibits ovarian carcinoma cell proliferation. Exp Biol Med (Maywood) 2006, 231:1132-1135.
14. Rosanò L, Di Castro V, Spinella F, Nicotra MR, Natali PG, Bagnato A. ZD4054, a specific antagonist of the endothelin A receptor, inhibits tumor growth and enhances paclitaxel activity in human ovarian carcinoma in vitro and in vivo. Mol Cancer Ther 2007, 6:2003-2011.
15. Ranson M, Wilson R, O'Sullivan JM, Maruoka M, Yamaguchi A, Cowan RA, Logue JP, Tomkinson HK, Tominaga N, Swaisland H, Oliver S, Usami M. Pharmacokinetic and tolerability profile of once-daily zibotentan (ZD4054) in Japanese and Caucasian patients with hormone-resistant prostate cancer. Int J Clin Pharm Ther 2010, 48:708-717.
16. Clarkson-Jones J, Kenyon A, Kemp J, Lenz E, Oliver S, Phillips P, Sandall D, Swaisland H. Metabolism of [14C]-ZD4054 in healthy volunteers. Eur J Cancer Suppl 2007, 5:114.
17. Swaisland HC, Oliver SD, Morris T, Jones HK, Bakhtyari A, Mackey A, McCormick AD, Slamon D, Hargreaves JA, Millar A, Taboada MT. 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. 10.1080/00498250902810944, 19480550.
18. Thadhani R, Pascual M, Bonventre JV. Acute renal failure. N Engl J Med 1996, 334:1448-1460. 10.1056/NEJM199605303342207, 8618585.
19. Oh WK, Proctor K, Nakabayashi M, Evan C, Tormey LK, Daskivich T, Antràs L, Smith M, Neary MP, Duh MS. The risk of renal impairment in hormone-refractory prostate cancer patients with bone metastases treated with zoledronic acid. Cancer 2007, 109:1090-1096. 10.1002/cncr.22504, 17311345.
20. Humphreys BD, Soiffer RJ, Magee CC. Renal failure associated with cancer and its treatment: an update. J Am Soc Nephrol 2005, 16:151-161. 10.1681/ASN.2004100843, 15574506.
21. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 1973, 60:646-649. 10.1002/bjs.1800600817, 4541913.
22. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976, 16:31-41. 10.1159/000180580, 1244564.
23. FDA Guidance for industry Pharmacokinetics in patients with impaired renal function: Study design, data analysis and impact on dosing and labeling. 1998, FDA Guidance for industry., http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory%20Information/Guidances/UCM072127.pdf
24. FDA Guidance for industry Pharmacokinetics in patients with impaired hepatic function: Study design, data analysis and impact on dosing and labeling. 2003, FDA Guidance for industry., http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072123.pdf
25. The European Agency for the evaluation of medicinal products Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function. 2004, The European Agency for the evaluation of medicinal products., http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003123.pdf
26. The European Agency for the evaluation of medicinal products Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. 2004, The European Agency for the evaluation of medicinal products., http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003122.pdf
27. World Medical Association (WMA). Declaration of Helsinki Ethical principles for medical research involving human subjects. 1964, Adopted by the 18th WMA General Assembly, Helsinki, Finland, June, World Medical Association (WMA). Declaration of Helsinki., http://www.wma.net/en/30publications/10policies/b3/index.html
28. European Medicines Agency ICH harmonised tripartite guideline; Guideline for good clinical practice E6(R1). 2002, European Medicines Agency., http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf
29. Rowland M, Tozer TN. Clinical Pharmacokinetics: Concepts and Applications. 1995, Lippincott, Williams & Wilkins, 3.
30. Schelman WR, Liu G, Wilding G, Morris T, Phung D, Dreicer R. A phase I study of zibotentan (ZD4054) in patients with metastatic, castrate-resistant prostate cancer. Invest New Drugs 2009, 29:118-125. 10.1007/s10637-009-9318-5, 3008512, 19763400.
31. James ND, Caty A, Payne H, Borre M, Zonnenberg BA, Beuzeboc P, McIntosh S, Morris T, De Phung H, Dawson NA. Final safety and efficacy analysis of the specific endothelin A receptor antagonist zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic for pain: A double-blind, placebo-controlled, randomised Phase II trial. BJU Int 2010, 106:966-973. 10.1111/j.1464-410X.2010.09638.x, 20840318.
32. Carducci MA, Nelson JB, Bowling MK, Rogers T, Eisenberger MA, Sinibaldi V, Donehower R, Leahy TL, Carr RA, Isaacson JD, Janus TJ, Andre A, Hosmane BS, Padley RJ. Atrasentan, an endothelin-receptor antagonist for refractory adenocarcinomas: safety and pharmacokinetics. J Clin Oncol 2002, 20:2171-2180. 10.1200/JCO.2002.08.028, 11956279.