A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors

Clinical Cancer Research

Volumn 17, Issue 19, 2011, Pages 6304-6312

  Atzori, Francesco ^a   Tabernero, Josep ^a   Cervantes, Andrés ^c   Prudkin, Ludmila ^a   Andreu, Jordi ^a   Rodríguez Braun, Edith ^c   Domingo, Amparo ^c   Guijarro, Jorge ^c   Gamez, Cristina ^b   Rodon, Jordi ^a   Di Cosimo, Serena ^a   Brown, Holly ^d   Clark, Jason ^d   Hardwick, James S ^d   Beckman, Robert A ^d   Hanley, William D ^d   Hsu, Karl ^d   Calvo, Emiliano ^a   Roselló, Susana ^c   Langdon, Ronald B ^d   Baselga, José ^a,e   more..

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^c UNIVERSITY OF VALENCIA   (Spain)

^d MERCK RESEARCH LABORATORIES   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DALOTUZUMAB; FLUORODEOXYGLUCOSE F 18; KI 67 ANTIGEN; METFORMIN; SOMATOMEDIN C RECEPTOR;

ADENOCARCINOMA; ADULT; ADVANCED CANCER; AGED; ANTIGEN EXPRESSION; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BACKACHE; BILE DUCT CARCINOMA; BLADDER METASTASIS; BLOOD SAMPLING; BREAST CANCER; CANCER PAIN; CHILL; COLORECTAL CANCER; DECREASED APPETITE; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; EWING SARCOMA; FEMALE; HAND FOOT SYNDROME; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; INFECTION; INJECTION SITE REACTION; LEUKOCYTOCLASTIC VASCULITIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MYOPATHY; NAUSEA; NEUROENDOCRINE TUMOR; OSTEOSARCOMA; OVARY CARCINOMA; PELVIS PAIN SYNDROME; PHASE 1 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROTEIN EXPRESSION; PURPURA; RECOMMENDED DRUG DOSE; SIDE EFFECT; SIGNAL TRANSDUCTION; SKIN BIOPSY; SOLID TUMOR; TREATMENT DURATION; TUMOR BIOPSY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; RECEPTOR, IGF TYPE 1;

EID: 80053525113     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-3336     Document Type: Article

References (33)

1. Pollak MN, Schernhammer ES, Hankinson SE. Insulin-like growth factors and neoplasia. Nat Rev Cancer 2004;4:505-18. (Pubitemid 38868620)
2. Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer 2008;8:915-28.
3. Baserga R. Targeting the IGF-1 receptor: from rags to riches. Eur J Cancer 2004;40:2013-5. (Pubitemid 39165531)
4. Chan JM, Stampfer MJ, Giovannucci E, Giovannucci E, Gann PH, Ma J, et al. Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study. Science 1998;279:563-6. (Pubitemid 28067285)
5. Hankinson SE, Willett WC, Colditz GA, Hunter DJ, Michaud DS, Deroo B, et al. Circulating concentrations of insulin-like growth factor-I and risk of breast cancer. Lancet 1998;351:1393-6. (Pubitemid 28209997)
6. Ma J, Pollak MN, Giovannucci E, Chan JM, Tao Y, Hennekens CH, et al. Prospective study of colorectal cancer risk in men and plasma levels of insulin-like growth factor (IGF)-I and IGF-binding protein-3. J Natl Cancer Inst 1999;91:620-5. (Pubitemid 29194048)
7. Peters G, Gongoll S, Langner C, Mengel M, Piso P, Klempnauer J, et al. IGF-1R, IGF-1 and IGF-2 expression as potential prognostic and predictive markers in colorectal-cancer. Virchows Arch 2003;443: 139-45. (Pubitemid 37056137)
8. Takahari D, Yamada Y, Okita NT, Honda T, Hirashima Y, Matsubara J, et al. Relationships of insulin-like growth factor-1 receptor and epidermal growth factor receptor expression to clinical outcomes in patients with colorectal cancer. Oncology 2009;76:42-8.
9. Baserga R. The insulin-like growth factor-I receptor as a target for cancer therapy. Expert Opin Ther Targets 2005;9:753-68. (Pubitemid 41131677)
10. Mitsiades CS, Mitsiades NS, McMullan CJ, Poulaki V, Shringarpure R, Akiyama M, et al. Inhibition of the insulin-like growth factor receptor-1 tyrosine kinase activity as a therapeutic strategy formultiplemyeloma, other hematologic malignancies, and solid tumors. Cancer Cell 2004;5: 221-30. (Pubitemid 38402114)
11. Yuen JS, Macaulay VM. Targeting the type 1 insulin-like growth factor receptor as a treatment for cancer. Expert Opin Ther Targets 2008;12: 589-603. (Pubitemid 351699478)
12. Gualberto A, Pollak M. Clinical development of inhibitors of the insulinlike growth factor receptor in oncology. Curr Drug Targets 2009;10: 923-36.
13. Gualberto A, Pollak M. Emerging role of insulin-like growth factor receptor inhibitors in oncology: early clinical trial results and future directions. Oncogene 2009;28:3009-21.
14. Karp DD, Pollak MN, Cohen RB, Eisenberg PD, Haluska P, Yin D, et al. Safety, pharmacokinetics, and pharmacodynamics of the insulin-like growth factor type 1 receptor inhibitor figitumumab (CP-751,871) in combination with paclitaxel and carboplatin. J Thorac Oncol 2009;4: 1397-403.
15. Karp DD, Paz-Ares LG, Novello S, Haluska P, Garland L, Cardenal F, et al. Phase II study of the anti-insulin-like growth factor type 1 receptor antibody CP-751,871 in combination with paclitaxel and carboplatin in previously untreated, locally advanced, or metastatic non-small-cell lung cancer. J Clin Oncol 2009;27: 2516-22.
16. Tolcher AW, Sarantopoulos J, Patnaik A, Papadopoulos K, Lin CC, Rodon J, et al. Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor 1. J Clin Oncol 2009;27:5800-7.
17. Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, et al. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol 2010;11:129-35.
18. Jassem J, Langer CJ, Karp DD, Mok T, Benner RJ, Green SJ, et al. Randomized, open label, phase III trial of figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). J Clin Oncol 2010; 28:7500.
19. Molife LR, Fong PC, Paccagnella L, Reid AH, Shaw HM, Vidal L, et al. The insulin-like growth factor-I receptor inhibitor figitumumab (CP-751,871) in combination with docetaxel in patients with advanced solid tumours: results of a phase Ib dose-escalation, open-label study. Br J Cancer 2010;103:332-9.
20. Reidy DL, Vakiani E, Fakih MG, Saif MW, Hecht JR, Goodman-Davis N, et al. Randomized, phase II study of the insulin-like growth factor-1 receptor inhibitor IMC-A12, with or without cetuximab, in patients with cetuximab-or panitumumab-refractory metastatic colorectal cancer. J Clin Oncol 2010;28:4240-6.
21. Gualberto A, Hixon ML, Karp DD, Li D, Green S, Dolled-Filhart M, et al. Pre-treatment levels of circulating free IGF-1 identify NSCLC patients who derive clinical benefit from figitumumab. Br J Cancer 2011;104: 68-74.
22. Goetsch L, Gonzalez A, Leger O, Beck A, Pauwels PJ, Haeuw JF, et al. A recombinant humanized anti-insulin-like growth factor receptor type I antibody (h7C10) enhances the antitumor activity of vinorelbine and anti-epidermal growth factor receptor therapy against human cancer xenografts. Int J Cancer 2005;113:316-28. (Pubitemid 39628325)
23. Broussas M, Dupont J, Gonzalez A, Blaecke A, Fournier M, Corvaïa N, et al. Molecular mechanisms involved in activity of h7C10, a humanized monoclonal antibody, to IGF-1 receptor. Int J Cancer 2009;124: 2281-93.
24. Pandini G, Wurch T, Akla B, Corvaia N, Belfiore A, Goetsch L. Functional responses and in vivo anti-tumour activity of h7C10: a humanised monoclonal antibody with neutralising activity against the insulin-like growth factor-1 (IGF-1) receptor and insulin/IGF-1 hybrid receptors. Eur J Cancer 2007;43:1318-27. (Pubitemid 46720250)
25. O'Reilly KE, Rojo F, She QB, Solit D, Mills GB, Smith D, et al. mTOR inhibition induces upstream receptor tyrosine kinase signaling and activates Akt. Cancer Res 2006;66:1500-8. (Pubitemid 43259931)
26. Tabernero J, Rojo F, Calvo E, Burris H, Judson I, Hazell K, et al. Doseand schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors. J Clin Oncol 2008;26: 1603-10.
27. Weroha SJ, Haluska P. IGF-1 receptor inhibitors in clinical trials-early lessons. J Mammary Gland Biol Neoplasia 2008;13:471-83.
28. Hidalgo M, Tirado Gomez M, Lewis N, Lewis N, Vuky JL, Taylor G, et al. A phase I study of MK-0646, a humanized monoclonal antibody against the insulin-like growth factor receptor type 1 (IGF1R) in advanced solid tumor patients in a q2 wk schedule. J Clin Oncol 2008;26:3520.
29. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004;93:2645-68. (Pubitemid 39506617)
30. Siena S, Sartore-Bianchi A, Di Nicolantonio F, Balfour J, Bardelli A. Biomarkers predicting clinical outcome of epidermal growth factor receptor-targeted therapy in metastatic colorectal cancer. J Natl Cancer Inst 2009;101:1308-24.
31. Yan L, Beckman RA. Pharmacogenetics and pharmacogenomics in oncology therapeutic antibody development. Biotechniques 2005;394: 565-8.
32. Di Cosimo S, Seoane J, Guzman M, Rojo F, Jimenez J, Anido J, et al. Combination of the mammalian target of rapamycin (mTOR) inhibitor everolimus (E) with the insulin like growth factor-1 receptor (IGF-1-R) inhibitor NVP-AEW-541: a mechanistic based anti-tumor strategy. J Clin Oncol 2005;26:3112.
33. Di Cosimo S, Bendell JC, Cervantes-Ruiperez A, Roda D, Prudkin L, Stein MN, et al. A phase I study of the oral mTOR inhibitor ridaforolimus (RIDA) in combination with the IGF-1R antibody dalotozumab (DALO) in patients (pts) with advanced solid tumors. J Clin Oncol 2010;28:3008.