A phase I study of weekly R1507, a human monoclonal antibody insulin-like growth factor-I receptor antagonist, in patients with advanced solid tumors

Clinical Cancer Research

Volumn 16, Issue 8, 2010, Pages 2458-2465

  Kurzrock, Razelle ^a   Patnaik, Amita ^b,g   Aisner, Joseph ^c   Warren, Terri ^a   Leong, Stephen ^d   Benjamin, Robert ^a   Eckhardt, S Gail ^d   Eid, Joseph E ^e   Greig, Gerard ^e   Habben, Kai ^f   McCarthy, Cinara D ^e   Gore, Lia ^d  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b CTRC Institute for Drug Development   (United States)

^c RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^d UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^e HOFFMANN LA ROCHE INC   (United States)

^f ROCHE DIAGNOSTICS GMBH   (Germany)

^g START   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; IMMUNOGLOBULIN ANTIBODY; METFORMIN; R 1507; REPAGLINIDE; SOMATOMEDIN C; UNCLASSIFIED DRUG;

ABNORMAL LABORATORY RESULT; ADULT; ADVANCED CANCER; AGED; ANOREXIA; APPENDIX CARCINOMA; AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; BRAIN ISCHEMIA; BREAST CANCER; CANCER FATIGUE; CANCER GROWTH; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EWING SARCOMA; FEMALE; HUMAN; HYPERBILIRUBINEMIA; LEIOMYOSARCOMA; LUNG CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MOUTH CARCINOMA; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE ADENOCARCINOMA; PROSTATE CANCER; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; RECEPTOR, IGF TYPE 1; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77950974697     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-09-3220     Document Type: Article

References (35)

1. Ryan PD, Goss PE. The emerging role of the insulin-like growth factor pathway as a therapeutic target in cancer. Oncologist 2008;13: 16-24. (Pubitemid 351206693)
2. Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer 2008;8:915-928
3. 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)
4. Ma J, Pollak MN, Giovannucci E, 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;91:620-625 (Pubitemid 29194048)
5. Giovannucci E, Pollak MN, Platz EA, et al. A prospective study of plasma insulin-like growth factor-1 and binding protein-3 and risk of colorectal neoplasia in women. Cancer Epidemiol Biomarkers Prev 2000;9:345-349 (Pubitemid 30265776)
6. Palmqvist R, Hallmans G, Rinaldi S, et al. Plasma insulin-like growth factor 1, insulin-like growth factor binding protein 3, and risk of colorectal cancer: a prospective study in northern Sweden. Gut 2002;50:642-646 (Pubitemid 34407490)
7. Chan JM, Stampfer MJ, Giovannucci E, et al. Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study. Science 1998;279:563-566 (Pubitemid 28067285)
8. Chan JM, Stampfer MJ, Ma J, et al. Insulin-like growth factor-I (IGF-I) and IGF binding protein-3 as predictors of advanced-stage prostate cancer. J Natl Cancer Inst 2002;94:1099-1106 (Pubitemid 34830730)
9. Harman SM, Metter EJ, Blackman MR, et al. Serum levels of insulin-like growth factor I (IGF-I), IGF-II, IGF-binding protein-3, and prostate-specific antigen as predictors of clinical prostate cancer. J Clin Endocrinol Metab 2000;85:4258-4265
10. Stattin P, Bylund A, Rinaldi S, et al. Plasma insulin-like growth factor-I, insulin-like growth factor-binding proteins, and prostate cancer risk: a prospective study. J Natl Cancer Inst 2000;92:1910-1917 (Pubitemid 32036921)
11. Rosen N, Yee D, Lippman ME, et al. Insulin-like growth factors in human breast cancer. Breast Cancer Res Treat 1991;18:S55-62 (suppl 1).
12. Angelloz-Nicoud P, Binoux M. Autocrine regulation of cell proliferation by the insulin-like growth factor (IGF) and IGF binding protein-3 protease system in a human prostate carcinoma cell line (PC-3). Endocrinology 1995;136:5485-5492
13. Rotsch M, Maasberg M, Erbil C, et al. Characterization of insulin-like growth factor 1 receptors and growth effects in human lung cancer cell lines. J Cancer Res Clin Oncol 1992;118:502-508
14. Culouscou JM, Shoyab M. Purification of a colon cancer cell growth inhibitor and its identification as an insulin-like growth factor binding protein. Cancer Res 1991;51:2813-2819
15. Sekyi-Otu A, Bell RS, Ohashi C, et al. Insulin-like growth factor 1 (IGF-1) receptors, IGF-1, and IGF-2 are expressed in primary human sarcomas. Cancer Res 1995;55:129-134
16. Bergmann U, Funatomi H, Kornmann M, et al. Increased expression of insulin receptor substrate-1 in human pancreatic cancer. Biochem Biophys Res Commun 1996;220:886-890 (Pubitemid 26198607)
17. Wolpin BM, Meyerhardt JA, Chan AT, et al. Insulin, the insulin-like growth factor axis, and mortality in patients with nonmetastatic colorectal cancer. J Clin Oncol 2009;27:176-185
18. Yee D, Favoni RE, Lebovic GS, et al. Insulin-like growth factor I expression by tumors of neuroectodermal origin with the t(11;22) chromosomal translocation. A potential autocrine growth factor. J Clin Invest 1990;86:1806-1814
19. Cironi L, Riggi N, Provero P, et al. IGF1 is a common target gene of Ewing's sarcoma fusion proteins in mesenchymal progenitor cells. PLoS ONE 2008;3:e2634.
20. Prieur A, Tirode F, Cohen P, et al. EWS/FLI-1 silencing and gene profiling of Ewing cells reveal downstream oncogenic pathways and a crucial role for repression of insulin-like growth factor binding protein 3. Mol Cell Biol 2004;24:7275-7283 (Pubitemid 39014452)
21. Zhan S, Shapiro DN, Helman LJ. Loss of imprinting of IGF2 in Ewing's sarcoma. Oncogene 1995;11:2503-2507 (Pubitemid 26023817)
22. Sun Y, Gao D, Liu Y, et al. IGF2 is critical for tumorigenesis by synovial sarcoma oncoprotein SYT-SSX1. Oncogene 2006;25:1042-1052 (Pubitemid 43277012)
23. Törnkvist M, Natalishvili N, Xie Y, et al. Differential roles of SS18-SSX fusion gene and insulin-like growth factor-1 receptor in synovial sarcoma cell growth. Biochem Biophys Res Commun 2008;368: 793-800.
24. Schnitzer T, Kuenkele KP, Rebers F, et al. Characterization of a recombinant, fully human monoclonal antibody directed against the human insulin-like growth factor-1 receptor. Poster #214 presented at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Prague, Czech Republic. 2006.
25. F. Hoffmann-La Roche Ltd.. IGF-1R (RO4858696) Roche Clinical Study Report-Protocol BO19373-Research Report 1027082. 2009.
26. Therasse P, Arbuck SG, Eisenhauer EA, et al, European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216
27. Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 2006;11:81-88 (Pubitemid 43227856)
28. Rodon J, Patnaik A, Stein M, et al. A phase I study of q3W R1507, a human monoclonal antibody IGF-1R antagonist in patients with advanced cancer. J Clin Oncol 2007;25:18S (suppl; abstr 3590).
29. Rodon J, Patnaik A, Stein M, et al. A phase I study of q3W R1507, a human monoclonal antibody IGF-1R (insulin-like growth factor receptor) antagonist in patients with advanced solid tumors. Poster A78 presented at the AACR Molecular Targets and Cancer Therapeutics Meeting, San Francisco. 2007.
30. Lacy MQ, Alsina M, Fonseca R, et al. Phase I, pharmacokinetic and pharmacodynamic study of the anti-insulinlike growth factor type 1 receptor monoclonal antibody CP-751,871 in patients with multiple myeloma. J Clin Oncol 2008;26:3196-3203
31. Clemmons DR. Involvement of insulin-like growth factor-I in the control of glucose homeostasis. Curr Opin Pharmacol 2006;6:620-625
32. Tolcher AW, Sarantopoulos J, Patnaik A, 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;27:5800-5807
33. Olmos D, Okuno S, Schuetze SM, et al. Safety, pharmacokinetics and preliminary activity of the anti-IGF-IR antibody CP-751,871 in patients with sarcoma. J Clin Oncol 2008;26:15S (suppl; abstr 10501).
34. Atzori F, Tabernero J, Cervantes A, et al. A phase I, pharmacokinetic (PK) and pharmacodynamic (PD) study of weekly (qw) MK-0646, an insulin-like growth factor-1 receptor (IGF1R) monoclonal antibody (MAb) in patients (pts) with advanced solid tumors. J Clin Oncol 2008;26:15S (suppl; abstr 3519).
35. Scotlandi K, Benini S, Sarti M, et al. Insulin-like growth factor I receptor-mediated circuit in Ewing's sarcoma/peripheral neuroectodermal tumor: a possible therapeutic target. Cancer Res 1996; 56:4570-4574 (Pubitemid 26338048)