Pharmacokinetics and Tolerability of Vandetanib in Chinese Patients With Solid, Malignant Tumors: An Open-Label, Phase I, Rising Multiple-Dose Study

Clinical Therapeutics

Volumn 33, Issue 3, 2011, Pages 315-327

  Zhang, Li ^a   Li, Su ^a   Zhang, Yang ^a   Zhan, Jing ^a   Zou, Ben Yan ^a   Smith, Robert ^b   Martin, Paul D ^b   Jiang, Yinrui ^b   Liao, Hai ^a   Guan, Zhongzhen ^a  

^a SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^b ASTRAZENECA   (United Kingdom)

Author keywords

Cancer; Chinese patients; Pharmacokinetics; Tolerability; Vandetanib

Indexed keywords

VANDETANIB;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BIOCHEMISTRY; BODY WEIGHT; CHINA; CHINESE; CLINICAL ARTICLE; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG FATALITY; DRUG HALF LIFE; DRUG TOLERABILITY; ELECTROCARDIOGRAM; EXFOLIATIVE DERMATITIS; FEMALE; HEMATOLOGY; HUMAN; HYPERTENSION; JAPANESE; MALE; MALIGNANT NEOPLASTIC DISEASE; MULTIPLE CYCLE TREATMENT; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; PLASMA CLEARANCE; QT PROLONGATION; RASH; SIDE EFFECT; SINGLE DRUG DOSE; SOLID TUMOR; THORAX PAIN; THYROID MEDULLARY CARCINOMA; URINALYSIS; URTICARIA; VITAL SIGN;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CHINA; COHORT STUDIES; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NEOPLASMS; PIPERIDINES; QUINAZOLINES; YOUNG ADULT;

EID: 79956029711     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.04.005     Document Type: Article

References (33)

1. Hennequin L.F., Stokes E.S., Thomas A.P., et al. Novel 4-anilinoquinazolines with C-7 basic side chains: design and structure activity relationship of a series of potent, orally active, VEGF receptor tyrosine kinase inhibitors. J Med Chem 2002, 45:1300-1312.
2. Wedge S.R., Ogilvie D.J., Dukes M., et al. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res 2002, 62:4645-4655.
3. Ciardiello F., Caputo R., Damiano V., et al. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res 2003, 9:1546-1556.
4. Carlomagno F., Vitagliano D., Guida T., et al. ZD6474, an orally available inhibitor of KDR tyrosine kinase activity, efficiently blocks oncogenic RET kinases. Cancer Res 2002, 62:7284-7290.
5. Vitagliano D., Carlomagno F., Motti M.L., et al. Regulation of p27Kip1 protein levels contributes to mitogenic effects of the RET/PTC kinase in thyroid carcinoma cells. Cancer Res 2004, 64:3823-3829.
6. Kowanetz M., Ferrara N. Vascular endothelial growth factor signaling pathways: therapeutic perspective. Clin Cancer Res 2006, 12:5018-5022.
7. Harari P.M. Epidermal growth factor receptor inhibition strategies in oncology. Endocr Relat Cancer 2004, 11:689-708.
8. Wells A. EGF receptor. Int J Biochem Cell Biol 1999, 31:637-643.
9. Woodburn J.R. The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 1999, 82:241-250.
10. Richardson D.S., Lai A.Z., Mulligan L.M. RET ligand-induced internalization and its consequences for downstream signaling. Oncogene 2006, 25:3206-3211.
11. Castellone M.D., De Falco V., Rao D.M., et al. The beta-catenin axis integrates multiple signals downstream from RET/papillary thyroid carcinoma leading to cell proliferation. Cancer Res 2009, 69:1867-1876.
12. Wells S.A., Gosnell J.E., Gagel R.F., et al. Vandetanib in metastatic hereditary medullary thyroid cancer: follow-up results of an open-label Phase II trial. J Clin Oncol 2007, 25:A6018.
13. Heymach J.V., Johnson B.E., Prager D., et al. Randomized, placebo-controlled Phase II study of vandetanib plus docetaxel in previously treated non small-cell lung cancer. J Clin Oncol 2007, 25:4270-4277.
14. Heymach J.V., Paz-Ares L., De Braud F., et al. Randomized Phase II study of vandetanib alone or with paclitaxel and carboplatin as first-line treatment for advanced non-small-cell lung cancer. J Clin Oncol 2008, 26:5407-5415.
15. Natale R.B., Bodkin D., Govindan R., et al. Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: results from a two-part, double-blind, randomized phase II study. J Clin Oncol 2009, 27:2523-2529.
16. de Boer R., Arrieta, Gottfried M., et al. Vandetanib plus pemetrexed versus pemetrexed as second-line therapy in patients with advanced non-small cell lung cancer (NSCLC): a randomized, double-blind Phase III trial (ZEAL). J Clin Oncol 2009, 27(15 suppl):A8010.
17. Herbst R.S., Sun Y., Eberhardt W.E., et al. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small cell lung cancer (ZODIAC): a double-blind, randomised, Phase 3 trial. Lancet Oncol 2010, 11:619-626.
18. Natale R.B., Thongprasert S., Greco F.A., et al. Vandetanib versus erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior cytotoxic chemotherapy: a randomized, double-blind Phase III trial (ZEST). J Clin Oncol 2009, 27(Suppl 15):A8009.
19. Holden S.N., Eckhardt S.G., Basser R., et al. Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 2005, 16:1391-1397.
20. Tamura T., Minami H., Yamada Y., et al. A Phase I dose-escalation study of ZD6474 in Japanese patients with solid, malignant tumors. J Thorac Oncol 2006, 1:1002-1009.
21. Oken M.M., Creech R.H., Tormey D.C., et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982, 5:649-655.
22. Phase I Chinese PK ClinicalTrials.gov, Accessed July 21, 2010. http://clinicaltrials.gov.
23. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly and amended by the 55th WMA General Assembly, Tokyo 2004 World Medical Association Declaration of Helsinki, Accessed November 10, 2010. http://www.wma.net/en/30publications/10policies/b3/index.html.
24. Guideline for Good Clinical Practice E6(R1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Accessed November 10, 2010. http://www.ich.org/LOB/media/MEDIA482.pdf.
25. Rowland M., Tozer T.N. Clinical Pharmacokinetics: Concepts and Applications 2010, Lippincott, Williams & Wilkins, Philadelphia, PA. 4th ed.
26. Beal S., Sheiner L.B. The NONMEM system. Am Stat 1980, 34:118-119.
27. Lindstrom M.L., Bates D.M. Nonlinear mixed effects models for repeated measures data. Biometrics 1990, 46:673-687.
28. Therasse P., Arbuck S.G., Eisenhauer E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
29. Technical guideline on pharmacokinetic studies State Food and Drug Administration, Accessed July 21, 2010. http://www.sda.gov.cn/gsz05106/07.pdf.
30. Herbst R.S., Heymach J.V., O'Reilly M.S., et al. Vandetanib (ZD6474): an orally available receptor tyrosine kinase inhibitor that selectively targets pathways critical for tumor growth and angiogenesis. Expert Opin Investig Drugs 2007, 16:239-249.
31. Solomon B.M., Jatoi A. Rash from EGFR inhibitors: opportunities and challenges for palliation. Curr Oncol Rep 2008, 10:304-308.
32. Dickler M.N., Rugo H.S., Eberle C.A., et al. A Phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer. Clin Cancer Res 2008, 14:7878-7883.
33. Sherman S.I., Wirth L.J., Droz J.P., et al. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med 2008, 359:31-42.