Phase I/II study of sunitinib malate in Japanese patients with gastrointestinal stromal tumor after failure of prior treatment with imatinib mesylate

Investigational New Drugs

Volumn 28, Issue 6, 2010, Pages 866-875

  Shirao, Kuniaki ^a   Nishida, Toshirou ^b   Doi, Toshihiko ^c   Komatsu, Yoshito ^d   Muro, Kei ^e,f   Li, Yinhua ^g   Ueda, Eiji ^g   Ohtsu, Atsushi ^c  

^a OITA UNIVERSITY   (Japan)

^b OSAKA UNIVERSITY   (Japan)

^c NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^d HOKKAIDO UNIVERSITY HOSPITAL   (Japan)

^e NATIONAL CANCER CENTER HOSPITAL   (Japan)

^f AICHI CANCER CENTER HOSPITAL   (Japan)

^g PFIZER INC   (United States)

Author keywords

Biomarkers; GIST; Japanese patients; Pharmacokinetics; Sunitinib

Indexed keywords

IMATINIB; STEM CELL FACTOR; SU 12662; SUNITINIB; UNCLASSIFIED DRUG; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASCITES; BLEEDING; CARDIOMYOPATHY; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL STROMAL TUMOR; HAND FOOT SYNDROME; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; HYPOGLYCEMIA; HYPOPHOSPHATEMIA; HYPOPROTEINEMIA; HYPOTHYROIDISM; JAPANESE; LIVER METASTASIS; LUNG METASTASIS; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NEPHROTIC SYNDROME; NEUTROPHIL COUNT; PERIANAL ABSCESS; PERITONEUM METASTASIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QT PROLONGATION; RECOMMENDED DRUG DOSE; REFLUX ESOPHAGITIS; SIDE EFFECT; SKIN DISCOLORATION; SKIN MANIFESTATION; STEADY STATE; STOMACH ULCER; THROMBOCYTE COUNT; TIME TO MAXIMUM PLASMA CONCENTRATION; TUMOR GROWTH;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; DEMOGRAPHY; FEMALE; GASTROINTESTINAL STROMAL TUMORS; HUMANS; INDOLES; JAPAN; MALE; MIDDLE AGED; NEOPLASM PROTEINS; PIPERAZINES; PYRIMIDINES; PYRROLES; SOLUBILITY; TREATMENT FAILURE; TUMOR MARKERS, BIOLOGICAL; YOUNG ADULT;

EID: 78549246206     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-009-9306-9     Document Type: Article

References (29)

1. CP Raut JA Morgan SW Ashley 2007 Current issues in gastrointestinal stromal tumors: incidence, molecular biology, and contemporary treatment of localized and advanced disease Curr Opin Gastroenterol 23 149 158 10.1097/MOG.0b013e32802086d0 17268243 (Pubitemid 46192969)
2. JC Trent RS Benjamin 2006 New developments in gastrointestinal stromal tumor Curr Opin Oncol 18 386 395 10.1097/01.cco.0000228747.02660.e2 16721136 (Pubitemid 44297252)
3. CL Corless JA Fletcher MC Heinrich 2004 Biology of gastrointestinal stromal tumors J Clin Oncol 22 3813 3825 1:CAS:528:DC%2BD2cXhtVCitb%2FL 10.1200/JCO.2004.05.140 15365079 (Pubitemid 41095223)
4. MC Heinrich CL Corless GD Demetri, et al. 2003 Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor J Clin Oncol 21 4342 4349 1:CAS:528:DC%2BD2cXpsVWqu7Y%3D 10.1200/JCO.2003.04.190 14645423 (Pubitemid 46621810)
5. CL Corless A Schroeder D Griffith, et al. 2005 PDGFRA mutations in gastrointestinal stromal tumors: frequency, spectrum and in vitro sensitivity to imatinib J Clin Oncol 23 5357 5364 1:CAS:528:DC%2BD2MXpslOrtLY%3D 10.1200/JCO.2005.14.068 15928335 (Pubitemid 46206989)
6. GD Demetri M von Mehren CD Blanke, et al. 2002 Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors N Engl J Med 347 472 480 1:CAS:528:DC%2BD38XmtV2nt7s%3D 10.1056/NEJMoa020461 12181401 (Pubitemid 34879334)
7. M Van Glabbeke J Verweij PG Casali, et al. 2005 Initial and late resistance to imatinib in advanced gastrointestinal stromal tumors are predicted by different prognostic factors: a European Organisation for Research and Treatment of Cancer-Italian Sarcoma Group-Australasian Gastrointestinal Trials Group study J Clin Oncol 23 5795 5804 10.1200/JCO.2005.11.601 16110036
8. J Verweij PG Casali J Zalcberg, et al. 2004 Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial Lancet 364 1127 1134 1:CAS:528:DC%2BD2cXnvVOiu7o%3D 10.1016/S0140-6736(04)17098- 0 15451219 (Pubitemid 39296599)
9. TJ Abrams LB Lee LJ Murray NK Pryer JM Cherrington 2003 SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer Mol Cancer Ther 2 471 478 1:CAS:528: DC%2BD3sXkvVersbw%3D 12748309
10. DB Mendel AD Laird X Xin, et al. 2003 In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship Clin Cancer Res 9 327 337 1:CAS:528:DC%2BD3sXnt1OrtA%3D%3D 12538485
11. AM O'Farrell TJ Abrams HA Yuen, et al. 2003 SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo Blood 101 3597 3605 10.1182/blood-2002-07-2307 12531805 (Pubitemid 36857948)
12. LJ Murray TJ Abrams KR Long, et al. 2003 SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model Clin Exp Metastasis 20 757 766 1:CAS:528:DC%2BD3sXpsV2ktbk%3D 10.1023/B:CLIN.0000006873.65590.68 14713109 (Pubitemid 38019277)
13. DW Kim YS Jo HS Jung, et al. 2006 An orally administered multi-target tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/PTC kinases J Clin Endocrinol Metab 91 4070 4076 1:CAS:528:DC%2BD28XhtFSjtbrN 10.1210/jc.2005-2845 16849418 (Pubitemid 44536887)
14. GD Demetri AT van Oosterom CR Garrett, et al. 2006 Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial Lancet 368 1329 1338 1:CAS:528:DC%2BD28XhtVOrtL%2FL 10.1016/S0140-6736(06)69446-4 17046465 (Pubitemid 44528723)
15. P Therasse SG Arbuck EA Eisenhauer, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 205 216 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437 (Pubitemid 30099779)
16. Cancer Therapy Evaluation Program. Common toxicity criteria (CTC) version 2.0. Bethesda, MD: National Cancer Institute, April 30, 1999 (available at http://ctep.cancer.gov/forms/CTCv20-4-30-992.pdf )
17. CL Bello L Sherman J Zhou, et al. 2006 Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects Anticancer Drugs 17 353 358 1:CAS:528:DC%2BD28XitVGnur8%3D 10.1097/00001813- 200603000-00015 16520665
18. SE DePrimo CL Bello J Smeraglia, et al. 2007 Circulating protein biomarkers of pharmacodynamic activity of sunitinib in patients with metastatic renal cell carcinoma: modulation of VEGF and VEGF-related proteins J Transl Med 5 32 10.1186/1479-5876-5-32 17605814 (Pubitemid 47226331)
19. S Faivre C Delbaldo K Vera, et al. 2006 Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer J Clin Oncol 24 25 35 1:CAS:528: DC%2BD28Xot1ChtQ%3D%3D 10.1200/JCO.2005.02.2194 16314617 (Pubitemid 46630490)
20. Demetri GD, Heinrich MC, Fletcher JA et al (2009) Molecular target modulation, imaging, and clinical evaluation of gastrointestinal stromal tumor patients treated with sunitinib malate after imatinib failure. Clin Cancer Res 15: in press
21. Rosen L, Mulay M, Wittner J et al (2003) Phase I trial of SU011248, a novel tyrosine kinase inhibitor in advanced solid tumors. Proc Am Soc Clin Oncol 22: (abstr. 765)
22. SUTENT (sunitinib malate): full prescribing information. New York, NY: Pfizer Inc., November, 2008 (available at http://www.pfizer.com/files/products/ uspisutent.pdf )
23. Houk BE, Bello CL, Kang D, Amantea M (2009) A population pharmacokinetic meta-analysis of sunitinib malate (SU11248) and its primary metabolite (SU12662) in healthy volunteers and oncology patients. Clin Cancer Res 15:2497-2506
24. T Nishida T Takahashi A Nishitani, et al. 2009 Sunitinib-resistant gastrointestinal stromal tumors harbor cis-mutations in the activation loop of the KIT gene Int J Clin Oncol 14 143 149 1:CAS:528:DC%2BD1MXkvFeqtb4%3D 10.1007/s10147-008-0822-y 19390946
25. TA Carter LM Wodicka NP Shah, et al. 2005 Inhibition of drug-resistant mutants of ABL, KIT, and EGF receptor kinases Proc Natl Acad Sci U S A 102 11011 11016 1:CAS:528:DC%2BD2MXnvVWjurg%3D 10.1073/pnas.0504952102 16046538 (Pubitemid 41105984)
26. H Prenen J Cools N Mentens, et al. 2006 Efficacy of the kinase inhibitor SU11248 against gastrointestinal stromal tumor mutants refractory to imatinib mesylate Clin Cancer Res 12 2622 2627 1:CAS:528:DC%2BD28XjvVaksrg%3D 10.1158/1078-0432.CCR-05-2275 16638875
27. DePrimo SE, Huang X, Blackstein M et al (2009) Circulating levels of soluble KIT serve as a biomarker for clinical outcome in gastrointestinal stromal tumor patients receiving sunitinib following imatinib failure. Clin Cancer Res 15: in press
28. HJ Burstein AD Elias HS Rugo, et al. 2008 Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane J Clin Oncol 26 1810 1816 1:CAS:528:DC%2BD1cXmsFemsb8%3D 10.1200/JCO.2007.14.5375 18347007
29. P Bono A Krause M von Mehren, et al. 2004 Serum KIT and KIT ligand levels in patients with gastrointestinal stromal tumors treated with imatinib Blood 103 2929 2935 1:CAS:528:DC%2BD2cXjsVahu70%3D 10.1182/blood-2003-10-3443 15070666 (Pubitemid 38451662)