Icrucumab, a fully human monoclonal antibody against the vascular endothelial growth factor receptor-1, in the treatment of patients with advanced solid malignancies: A Phase 1 study

Investigational New Drugs

Volumn 32, Issue 2, 2014, Pages 303-311

  Lorusso, Patricia M ^a   Krishnamurthi, Smitha ^b   Youssoufian, Hagop ^c   Hall, Nancy ^d,f   Fox, Floyd ^d   Dontabhaktuni, Aruna ^d   Grebennik, Dmitri ^d,g   Remick, Scot ^e  

^a WAYNE STATE UNIVERSITY   (United States)

^b UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^c Ziopharm Oncology Inc   (United States)

^d ELI LILLY AND COMPANY   (United States)

^e WEST VIRGINIA UNIVERSITY   (United States)

^f EISAI INC   (United States)

^g KYOWA HAKKO KOGYO CO LTD   (Japan)

Author keywords

Antitumor; Human cancer; Icrucumab; Monoclonal antibody; Phase 1

Indexed keywords

ICRUCUMAB;

ABDOMINAL DISTENSION; ADULT; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ASTHENIA; BACKACHE; CHILL; CLINICAL ARTICLE; COHORT ANALYSIS; COLORECTAL TUMOR; CONFERENCE PAPER; CONSTIPATION; CONTROLLED STUDY; COUGHING; DEHYDRATION; DIARRHEA; DISEASE DURATION; DIZZINESS; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DYSPHAGIA; DYSPNEA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPOKALEMIA; HYPONATREMIA; HYPOXIA; INSOMNIA; LUNG SMALL CELL CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; NAUSEA; OPEN STUDY; OVARY TUMOR; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; SINGLE DRUG DOSE; TACHYCARDIA; THYROID TUMOR; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-1;

EID: 84896388976     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-9998-8     Document Type: Conference Paper

References (25)

1. Sawano A, Iwai S, Sakurai Y, Ito M, Shitara K, Nakahata T, Shibuya M (2001) Flt-1, vascular endothelial growth factor receptor 1, is a novel cell surface marker for the lineage of monocyte-macrophages in humans. Blood 97(3):785-791
2. Sato K, Sasaki R, Ogura Y, Shimoda N, Togashi H, Terada K, Sugiyama T, Kakinuma H, Ogawa O, Kato T (1998) Expression of vascular endothelial growth factor gene and its receptor (flt-1) gene in urinary bladder cancer. Tohoku J Exp Med 185(3):173-184
3. Decaussin M, Sartelet H, Robert C, Moro D, Claraz C, Brambilla C, Brambilla E (1999) Expression of vascular endothelial growth factor (VEGF) and its two receptors (VEGF-R1-Flt1 and VEGF-R2-Flk1/KDR) in non-small cell lung carcinomas (NSCLCs): correlation with angiogenesis and survival. J Pathol 188(4):369-377
4. Wang ES, Teruya-Feldstein J, Wu Y, Zhu Z, Hicklin DJ, Moore MA (2004) Targeting autocrine and paracrine VEGF receptor pathways inhibits human lymphoma xenografts in vivo. Blood 104:2893-2902
5. Fischer C, Mazzone M, Jonckx B, Carmeliet P (2008) FLT1 and its ligands VEGFB and PlGF: drug targets for anti-angiogenic therapy? Nat Rev Cancer 8:942-956
6. Schwartz JD, Rowinsky EK, Youssoufian H, Pytowski B, Wu Y (2010) Vascular endothelial growth factor receptor-1 in human cancer: concise review and rationale for development of IMC-18F1 (Human antibody targeting vascular endothelial growth factor receptor-1). Cancer 116(4 suppl):1027-1032. doi: 10.1002/cncr.24789
7. Vincent L, Jin DK, Karajannis MA, Shido K, Hooper AT, Rashbaum WK, Pytowski B, Wu Y, Hicklin DJ, Zhu Z, Bohlen P, Niesvizky R, Rafii S (2005) Fetal stromal-dependent paracrine and intracrine vascular endothelial growth factor-a/vascular endothelial growth factor receptor-1 signaling promotes proliferation and motility of human primary myeloma cells. Cancer Res 65(8):3185-3192
8. Kaplan RN, Rafii S, Lyden D (2006) Preparing the "soil": the premetastatic niche. Cancer Res 66:11089-11093
9. Lyden D, Hattori K, Dias S, Costa C, Blaikie P, Butros L, Chadburn A, Heissig B, Marks W, Witte L, Wu Y, Hicklin D, Zhu Z, Hackett NR, Crystal RG, Moore MA, Hajjar KA, Manova K, Benezra R, Rafii S (2001) Impaired recruitment of bone-marrow-derived endothelial and hematopoietic precursor cells blocks tumor angiogenesis and growth. Nat Med 7(11):1194-1201
10. Pollard JW (2004) Tumour-educated macrophages promote tumour progression and metastasis. Nat Rev Cancer 4:71-78
11. Hiratsuka S, Nakamura K, Iwai S, Murakami M, Itoh T, Kijima H, Shipley JM, Senior RM, Shibuya M (2002) MMP9 induction by vascular endothelial growth factor receptor-1 is involved in lung-specific metastasis. Cancer Cell 2(4):289-300
12. Wu Y, Zhong Z, Huber J, Bassi R, Finnerty B, Corcoran E, Li H, Navarro E, Balderes P, Jimenez X, Koo H, Mangalampalli VR, Ludwig DL, Tonra JR, Hicklin DJ (2006) Anti-vascular endothelial growth factor receptor-1 antagonist antibody as a therapeutic agent for cancer. Clin Cancer Res 12(21):6573-6584
13. Waldner MJ, Neurath MF (2012) Targeting the VEGF signaling pathway in cancer therapy. Expert Opin Ther Targets 16(1):5-13. doi: 10.1517/14728222.2011. 641951
14. Brekken RA, Overholser JP, Stastny VA, Waltenberger J, Minna JD, Thorpe PE (2000) Selective inhibition of vascular endothelial growth factor (VEGF) receptor 2 (KDR/Flk-1) activity by a monoclonal anti-VEGF antibody blocks tumor growth in mice. Cancer Res 60(18):5117-5124
15. Shibuya M, Claesson-Welsh L (2006) Signal transduction by VEGF receptors in regulation of angiogenesis and lymphangiogenesis. Exp Cell Res 312(5):549-560
16. Cao Y (2009) Positive and negative modulation of angiogenesis by VEGFR1 ligands. Sci Signal 2(59):re1. doi: 10.1126/scisignal.259re1
17. Hicklin DJ, Ellis LM (2005) Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J Clin Oncol 23:1011-1027
18. Roskoski R Jr (2007) Vascular endothelial growth factor (VEGF) signaling in tumor progression. Crit Rev Oncol Hematol 62(3):179-213
19. Brekken RA, Huang X, King SW, Thorpe PE (1998) Vascular endothelial growth factor as a marker of tumor endothelium. Cancer Res 58(9):1952-1959
20. Grothey A, Galanis E (2009) Targeting angiogenesis: progress with anti-VEGF treatment with large molecules. Nat Rev Clin Oncol 6(9):507-518. doi: 10.1038/nrclinonc.2009.110
21. Sunshine SB, Dallabrida SM, Durand E, Ismail NS, Bazinet L, Birsner AE, Sohn R, Ikeda S, Pu WT, Kulke MH, Javaherian K, Zurakowski D, Folkman JM, Rupnick M (2012) Endostatin lowers blood pressure via nitric oxide and prevents hypertension associated with VEGF inhibition. Proc Natl Acad Sci U S A 109(28):11306-11311. doi: 10.1073/pnas.1203275109
22. Dienstmann R, Braña I, Rodon J, Tabernero J (2011) Toxicity as a biomarker of efficacy of molecular targeted therapies: focus on EGFR and VEGF inhibiting anticancer drugs. Oncologist 16(12):1729-1740. doi: 10.1634/theoncologist.2011-0163
23. Robinson ES, Khankin EV, Karumanchi SA, Humphreys BD (2010) Hypertension induced by vascular endothelial growth factor signaling pathway inhibition: mechanisms and potential use as a biomarker. Semin Nephrol 30(6):591-601. doi: 10.1016/j.semnephrol 2010.09.007
24. Ferroni P, Della-Morte D, Palmirotta R, Rundek T, Guadagni F, Roselli M (2012) Angiogenesis and hypertension: the dual role of anti-hypertensive and anti-angiogenic therapies. Curr Vasc Pharmacol 10(4):479-493
25. Thanigaimani S, Kichenadasse G, Mangoni AA (2011) The emerging role of vascular endothelial growth factor (VEGF) in vascular homeostasis: lessons from recent trials with anti-VEGF drugs. Curr Vasc Pharmacol 9(3):358-380