Increased bioavailability of intravenous versus oral Cl-1033, a Pan erbB tyrosine kinase inhibitor: Results of a phase I pharmacokinetic study

Clinical Cancer Research

Volumn 12, Issue 15, 2006, Pages 4645-4651

  Simon, George R ^a   Garrett, Christopher R ^a   Olson, Stephen C ^b   Langevin, Michael ^a   Eiseman, Irene A ^b   Mahany, John J ^a   Williams, Charles C ^a   Lush, Richard ^a   Daud, Adil ^a   Munster, Pamela ^a   Chiappori, Alberto ^a   Fishman, Mayer ^a   Bepler, Gerold ^a   Lenehan, Peter F ^b   Sullivan, Daniel M ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANERTINIB; CL 1033; PROTEIN TYROSINE KINASE INHIBITOR; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BIOAVAILABILITY; BREAST CANCER; CLINICAL TRIAL; COLORECTAL CARCINOMA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG STRUCTURE; DYSPNEA; FEMALE; FLUSHING; GASTROINTESTINAL SYMPTOM; HEAD AND NECK CANCER; HUMAN; HYPERSENSITIVITY; INFECTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MELANOMA; MYALGIA; NAUSEA; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SARCOMA; SIDE EFFECT; SKIN TOXICITY; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; FEMALE; FOLLOW-UP STUDIES; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORPHOLINES; NEOPLASMS; PREDICTIVE VALUE OF TESTS; PROTEIN KINASE INHIBITORS; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 33748048505     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-2379     Document Type: Article

References (31)

1. Klapper LN, Kirschbaum MH, Sela M, Yarden Y. Biochemical and clinical implications of the ErbB/HER signaling network of growth factor receptors. Adv Cancer Res 2000;77:25-79.
2. Lemmon MA, Schlessinger J. Regulation of signal transduction and signal diversity by receptor oligomerization. Trends Biochem Sci 1994;19:459-63.
3. Albanell J, Rojo F, Averbuch S, et al. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. J Clin Oncol 2002;20:110-24.
4. Simon GR, Ruckdeschel JC, Williams C, et al. Gefitinib (ZD1839) in previously treated advanced non-small-cell lung cancer: experience from a single institution. Cancer Control 2003;10:388-95.
5. Giatromanolaki A, Koukourakis MI, O'Byrne K, et al. Non-small cell lung cancer: c-erbB-2 overexpression correlates with low angiogenesis and poor prognosis. Anticancer Res 1996;16:3819-25.
6. Tang CK, Perez C, Grunt T, Waibel C, Cho C, Lupu R. Involvement of heregulin-β2 in the acquisition of the hormone-independent phenotype of breast cancer cells. Cancer Res 1996;56:3350-8.
7. Calvo E, Tolcher AW, Hammond LA, et al. Administration of CI-1033, an irreversible pan-erbB tyrosine kinase inhibitor, is feasible on a 7-day on, 7-day off schedule: a phase I pharmacokinetic and food effect study. Clin Cancer Res 2004;10:7112-20.
8. Schwartz S, Jr., Caceres C, Morote J, et al. Gains of the relative genomic content of erbB-1 and erbB-2 in prostate carcinoma and their association with metastasis. Int J Oncol 1999;14:367-71.
9. Leung HY, Weston J, Gullick WJ, Williams G. A potential autocrine loop between heregulin-α and erbB-3 receptor in human prostatic adenocarcinoma. Br J Urol 1997;79:212-6.
10. Almadori G, Cadoni G, Galli J, et al. Epidermal growth factor receptor expression in primary laryngeal cancer: an independent prognostic factor of neck node relapse. Int J Cancer 1999;84:188-91.
11. Hurtt MR, Moossy J, Donovan-Peluso M, Locker J. Amplification of epidermal growth factor receptor gene in gliomas: histopathology and prognosis. J Neuropathol Exp Neurol 1992;51:84-90.
12. Scambia G, Benedetti-Panici P, Ferrandina G, et al. Epidermal growth factor, oestrogen and progesterone receptor expression in primary ovarian cancer: correlation with clinical outcome and response to chemotherapy. Br J Cancer 1995;72:361-6.
13. Meden H, Kuhn W. Overexpression of the oncogene c-erbB-2 (HER2/neu) in ovarian cancer: a new prognostic factor. Eur J Obstet Gynecol Reprod Biol 1997;71:173-9.
14. Hirono Y, Tsugawa K, Fushida S, et al. Amplification of epidermal growth factor receptor gene and its relationship to survival in human gastric cancer. Oncology 1995;52:182-8.
15. Yonemura Y, Ninomiya I, Yamaguchi A, et al. Evaluation of immunoreactivity for erbB-2 protein as a marker of poor short-term prognosis in gastric cancer. Cancer Res 1991;51:1034-8.
16. Fry DW, Bridges AJ, Denny WA, et al. Specific, irreversible inactivation of the epidermal growth factor receptor and erbB2, by a new class of tyrosine kinase inhibitor. Proc Natl Acad Sci U S A 1998;95:12022-7.
17. Fry DW. Site-directed irreversible inhibitors of the erbB family of receptor tyrosine kinases as novel chemotherapeutic agents for cancer. Anticancer Drug Des 2000;15:3-16.
18. Grunwald V, Hidalgo M. Developing inhibitors of the epidermal growth factor receptor for cancer treatment. J Natl Cancer Inst 2003;95:851-67.
19. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
20. Nemunaitis J, Eiseman I, Cunningham C, et al. Phase 1 clinical and pharmacokinetics evaluation of oral CI-1033 in patients with refractory cancer. Clin Cancer Res 2005;11:3846-53.
21. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. J Clin Oncol 2003;21:2237-46.
22. Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003;290:2149-58.
23. Cella D, Herbst RS, Lynch TJ, et al. Clinically meaningful improvement in symptoms and quality of life for patients with non-small-cell lung cancer receiving gefitinib in a randomized controlled trial. J Clin Oncol 2005;23:2946-54.
24. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129-39.
25. Janne PA, Gurubhagavatula S, Yeap BY, et al. Outcomes of patients with advanced non-small cell lung cancer treated with gefitinib (ZD1839, "Iressa") on an expanded access study. Lung Cancer 2004;44:221-30.
26. Tamura K, Fukuoka M. Gefitinib in non-small cell lung cancer. Expert Opin Pharmacother 2005;6:985-93.
27. Baselga J, Arteaga CL. Critical update and emerging trends in epidermal growth factor receptor targeting in cancer. J Clin Oncol 2005;23:2445-59.
28. Hirsch FR, Witta S. Biomarkers for prediction of sensitivity to EGFR inhibitors in non-small cell lung cancer. Curr Opin Oncol 2005;17:118-22.
29. Scagliotti GV, Selvaggi G, Novello S, Hirsch FR. The biology of epidermal growth factor receptor in lung cancer. Clin Cancer Res 2004;10:4227-32s.
30. Hirsch FR, Varella-Garcia M, Bunn PA, Jr., et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol 2003;21:3798-807.
31. Hirsch FR, Scagliotti GV, Langer CJ, Varella-Garcia M, Franklin WA. Epidermal growth factor family of receptors in preneoplasia and lung cancer: perspectives for targeted therapies. Lung Cancer 2003;41:S29-42.