Evaluation of α2-integrin expression as a biomarker for tumor growth inhibition for the investigational integrin inhibitor E7820 in preclinical and clinical studies

AAPS Journal

Volumn 13, Issue 2, 2011, Pages 230-239

  Keizer, Ron J ^a   Funahashi, Y ^b   Semba, T ^b   Wanders, J ^c   Beijnen, J H ^a,d   Schellens, J H M ^c,d   Huitema, A D R ^a  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b EISAI CO LTD   (Japan)

^c NETHERLANDS CANCER INSTITUTE   (Netherlands)

^d UTRECHT UNIVERSITY   (Netherlands)

Author keywords

biomarker; E7820; modeling and simulation; oncology; pharmacodynamics

Indexed keywords

ALPHA2 INTEGRIN; ANGIOGENESIS INHIBITOR; E 7820; UNCLASSIFIED DRUG;

ADULT; AGED; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER INHIBITION; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG EXPOSURE; DRUG HALF LIFE; FEMALE; HUMAN; HUMAN CELL; LYMPHOMA; MALE; MOUSE; NONHUMAN; PANCREAS CARCINOMA; PHASE 1 CLINICAL TRIAL; PROTEIN EXPRESSION; REPEATED DRUG DOSE; SINGLE DRUG DOSE; SOLID TUMOR; THROMBOCYTE; TUMOR GROWTH; TUMOR VOLUME;

ADULT; AGED; AGED, 80 AND OVER; ANIMALS; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INDOLES; INTEGRIN ALPHA2; MALE; MICE; MICE, NUDE; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASM TRANSPLANTATION; NEOPLASMS; NONLINEAR DYNAMICS; PANCREATIC NEOPLASMS; SULFONAMIDES; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 79957518252     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9260-2     Document Type: Article

References (18)

1. T Semba Y Funahashi N Ono, et al. 2004 An angiogenesis inhibitor E7820 shows broad-spectrum tumor growth inhibition in a xenograft model: possible value of integrin alpha2 on platelets as a biological marker Clin Cancer Res 10 1430 1438 14977846 10.1158/1078-0432.CCR-0109-03 1:CAS:528:DC%2BD2cXhsVGjsb8%3D (Pubitemid 38365238)
2. Y Funahashi NH Sugi T Semba, et al. 2002 Sulfonamide derivative, E7820, is a unique angiogenesis inhibitor suppressing an expression of integrin alpha2 subunit on endothelium Cancer Res 62 6116 6123 12414636 1:CAS:528: DC%2BD38XosF2msrY%3D (Pubitemid 35244460)
3. DR Senger CA Perruzzi M Streit VE Koteliansky AR de Fougerolles M Detmar 2002 The alpha(1)beta(1) and alpha(2)beta(1) integrins provide critical support for vascular endothelial growth factor signaling, endothelial cell migration, and tumor angiogenesis Am J Pathol 160 195 204 11786413 10.1016/S0002-9440(10) 64363-5 1:CAS:528:DC%2BD38XnvFehuw%3D%3D (Pubitemid 34052280)
4. MM Mita AC Mita M Goldston, et al. 2005 Pharmacokinetics (PK) and pharmacodynamics (PD) of E7820-an oral sulfonamide with novel, alpha-2 integrin mediated antiangiogenic properties: results of a phase I study J Clin Oncol (Meeting Abstracts) 23 3082
5. Keizer RJ, Zamacona M, Jansen M, et al. Application of population pharmacokinetic modeling in early clinical development of the anticancer agent E7820 [Internet]. Investigational New Drugs 2008;[cited 2008 Aug 25] Available from: http://www.ncbi.nlm.nih.gov/pubmed/18712503
6. MB Sawyer S Iqbal H Lenz, et al. 2010 Phase II study of E7820 in combination with cetuximab in subjects (pts) with metastatic and refractory colorectal cancer (CRC) J Clin Oncol (Meeting Abstracts) 28 3537
7. C Tanaka T O'Reilly JM Kovarik, et al. 2008 Identifying optimal biologic doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic data J Clin Oncol 26 1596 1602 18332467 1:CAS:528:DC%2BD1cXltlWiu7Y%3D
8. S Wang Q Zhou JM Gallo 2009 Demonstration of the equivalent pharmacokinetic/pharmacodynamic dosing strategy in a multiple-dose study of gefitinib Mol Cancer Ther 8 1438 1447 19509243 10.1158/1535-7163.MCT-09-0089 1:CAS:528:DC%2BD1MXntVKgsLY%3D
9. Piraña and PCluster: a modeling environment and cluster infrastructure for NONMEM. Keizer RJ, van Benten M, Beijnen JH, Schellens JH, Huitema AD. Comput Methods Programs Biomed. 2011;101(1):72-9.
10. Holford, N. VPC, the visual predictive check-superiority to standard diagnostic (Rorschach) plots. In: PAGE 2005. 2005.
11. NL Dayneka V Garg WJ Jusko 1993 Comparison of four basic models of indirect pharmacodynamic responses J Pharmacokinet Biopharm 21 457 478 8133465 10.1007/BF01061691 1:CAS:528:DyaK2cXitlGhsb0%3D (Pubitemid 24025269)
12. C Dansirikul H Silber M Karlsson 2008 Approaches to handling pharmacodynamic baseline responses J Pharmacokinet Pharmacodyn 35 269 283 18446428 10.1007/s10928-008-9088-2 1:CAS:528:DC%2BD1cXosVGiu74%3D
13. A Iliadis D Barbolosi 2000 Optimizing drug regimens in cancer chemotherapy by an efficacy-toxicity mathematical model Comput Biomed Res 33 211 226 10860586 10.1006/cbmr.2000.1540 1:CAS:528:DC%2BD3cXktVKitbg%3D (Pubitemid 30432556)
14. M Simeoni P Magni C Cammia, et al. 2004 Predictive pharmacokinetic- pharmacodynamic modeling of tumor growth kinetics in xenograft models after administration of anticancer agents Cancer Res 64 1094 1101 14871843 10.1158/0008-5472.CAN-03-2524 1:CAS:528:DC%2BD2cXhtFCgsbc%3D (Pubitemid 38176915)
15. MM Mita AC Mita A Ricart, et al. 2006 Phase I study of an anti-angiogenic agent with a novel mechanism of action E7820: Safety, pharmacokinetics (PK) and pharmacodynamic (PD) studies in patients (pts) with solid tumors J Clin Oncol (Meeting Abstracts) 24 3048
16. GC Alghisi C Rüegg 2006 Vascular integrins in tumor angiogenesis: mediators and therapeutic targets Endothelium 13 113 135 16728329 10.1080/10623320600698037 1:CAS:528:DC%2BD28XmvV2jt7w%3D (Pubitemid 44173112)
17. H Jin J Varner 2004 Integrins: roles in cancer development and as treatment targets Br J Cancer 90 561 565 14760364 10.1038/sj.bjc.6601576 1:CAS:528:DC%2BD2cXoslKjug%3D%3D (Pubitemid 38297190)
18. L Bueno DP de Alwis C Pitou, et al. 2008 Semi-mechanistic modelling of the tumour growth inhibitory effects of LY2157299, a new type I receptor TGF-beta kinase antagonist, in mice Eur J Cancer 44 142 150 18039567 10.1016/j.ejca.2007.10.008 1:CAS:528:DC%2BD2sXhsVOrurrL (Pubitemid 350256941)