Tivozanib: Current status and future directions in the treatment of solid tumors

Expert Opinion on Investigational Drugs

Volumn 21, Issue 12, 2012, Pages 1851-1859

  Pal, Sumanta K ^a   Bergerot, Paulo G ^b   Figlin, Robert A ^c  

^a CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^b Health Department of Federal District (SES)   (Brazil)

^c CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

AV 951; Breast cancer; Gastrointestinal; Phase I; Renal cell carcinoma; Tivozanib

Indexed keywords

BEVACIZUMAB; BIOLOGICAL MARKER; CAPECITABINE; CYTOTOXIC AGENT; FLUOROURACIL; OXALIPLATIN; PACLITAXEL; SORAFENIB; TEMSIROLIMUS; TIVOZANIB; VASCULOTROPIN;

ALOPECIA; ASTHENIA; ATAXIA; BREAST CANCER; COLORECTAL CANCER; DIARRHEA; DRUG ACTIVITY; DRUG EFFICACY; DYSPHONIA; DYSPNEA; FATIGUE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HAND FOOT SYNDROME; HEART PALPITATION; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; KIDNEY CARCINOMA; KIDNEY METASTASIS; MEDICAL LITERATURE; MEDLINE; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMOPERITONEUM; PROTEINURIA; RANDOMIZATION; REVIEW; SIDE EFFECT; SYSTEMATIC REVIEW;

ANIMALS; ANTINEOPLASTIC AGENTS; HUMANS; NEOPLASMS; PHENYLUREA COMPOUNDS; QUINOLINES; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR;

EID: 84868674212     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2012.733695     Document Type: Review

References (49)

1. Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med 1971;285(21):1182-6
2. Plate KH, Breier G, Millauer B, et al. Up-regulation of vascular endothelial growth factor and its cognate receptors in a rat glioma model of tumor angiogenesis. Cancer Res 1993;53(23):5822-7
3. Toi M, Inada K, Suzuki H, Tominaga T. Tumor angiogenesis in breast cancer: its importance as a prognostic indicator and the association with vascular endothelial growth factor expression. Breast Cancer Res Treat 1995;36(2):193-204
4. Ferrara N. The role of vascular endothelial growth factor in pathological angiogenesis. Breast Cancer Res Treat 1995;36(2):127-37
5. Kim KJ, Li B, Winer J, et al. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature 1993;362(6423):841-4
6. Asano M, Yukita A, Matsumoto T, et al. Inhibition of tumor growth and metastasis by an immunoneutralizing monoclonal antibody to human vascular endothelial growth factor/vascular permeability factor121. Cancer Res 1995;55(22):5296-301
7. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355(24):2542-50
8. FDA Approval for Bevacizumab. Available from: http://www.cancer.gov/ cancertopics/druginfo/fda-bevacizumab [Last accessed 8 August 2012]
9. Vredenburgh JJ, Desjardins A, Herndon JE et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol 2007;25(30):4722-9
10. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350(23):2335-42
11. NCT00703326: a Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer. Available from: http://www.clinicaltrials.gov [Last accessed 8 August 2012]
12. NCT01170663: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine. Available from: http://www.clinicaltrials. gov [Last accessed 8 August 2012]
13. NCT01140347: A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH). Available from: http://www.clinicaltrials.gov [Last accessed 8 August 2012]
14. NCT01183780: A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine. Available from: http://www.clinicaltrials. gov [Last accessed 8 August 2012]
15. NCT01168973: a Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy. Available from: http://www.clinicaltrials.gov [Last accessed 8 August 2012]
16. Demetri GD, Huang X, Garrett CR, et al. Novel statistical analysis of long-term survival to account for crossover in a phase III trial of sunitinib (SU) vs. placebo (PL) in advanced GIST after imatinib (IM) failure. J Clin Oncol (Meeting Abstracts) 2008;26(15 Suppl):10524
17. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359(4):378-90
18. Gomez-Rivera F, Santillan-Gomez AA, Younes MN, et al. The tyrosine kinase inhibitor, AZD2171, inhibits vascular endothelial growth factor receptor signaling and growth of anaplastic thyroid cancer in an orthotopic nude mouse model. Clin Cancer Res 2007;13(15 Pt 1):4519-27
19. Skolarikos AA, Papatsoris AG, Alivizatos G, Deliveliotis C. Molecular pathogenetics of renal cancer. Am J Nephrol 2006;26(3):218-31
20. Kim WY, Kaelin WG. Role of VHL gene mutation in human cancer. J Clin Oncol 2004;22(24):4991-5004
21. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356(2):125-34
22. Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27(22):3584-90
23. Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28(6):1061-8
24. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011;378(9807):1931-9
25. TIVO-1 study in renal cell carcinoma. Available from: http://www.epgonline. org/news/2012/Aug/Updated-results-of-TIVO-1.cfm [Last accessed 23 September 2012]
26. Tivozanib: pubChem Compound Summary. Available from: http://pubchem.ncbi. nlm.nih.gov/summary/summary.cgi?cid=9911830 [Last accessed 12 August 2012]
27. Nakamura K, Taguchi E, Miura T, et al. KRN951, a highly potent inhibitor of vascular endothelial growth factor receptor tyrosine kinases, has antitumor activities and affects functional vascular properties. Cancer Res 2006;66(18):9134-42
28. Eskens FA, de Jonge MJ, Bhargava P, et al. Biologic and clinical activity of tivozanib (AV-951, KRN-951), a selective inhibitor of VEGF receptor-1,-2, and-3 tyrosine kinases, in a 4-week-on, 2-week-off schedule in patients with advanced solid tumors. Clin Cancer Res 2011;17(22):7156-63
29. Eskens F, Oldenhuis CN, Bhargava P, et al. A phase Ib, open-label, dose-escalation study of tivozanib and FOLFOX6 in patients (pts) with advanced gastrointestinal (GI) tumors. ASCO Meeting Abstr 2011;29(4 Suppl):549
30. Eskens F, Oldenhuis CN, Loos WJ, et al. Final results of a phase Ib study of tivozanib and FOLFOX6 in patients (pts) with advanced gastrointestinal (GI) tumors. ASCO Meeting Abstr 2012;30(15 Suppl):4132
31. NCT01478594: a Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects. Available from: http://www.clinicaltrials.gov [Last accessed 12 August 2012]
32. NCT01306630: A Phase 1b, Open-Label, Dose-Escalating Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda) in Subjects With Advanced Solid Tumors. Available from: http://www.clinicaltrials.gov [Last accessed 12 August 2012]
33. Mayer EL, Scheulen ME, Beckman J, et al. Combination of tivozanib (AV-951) with weekly paclitaxel for metastatic breast cancer: results of a phase I study. ASCO Meeting Abstr 2011;29(15 Suppl):1092
34. Nosov D, Bhargava P, Esteves WB, et al. Final analysis of the phase II randomized discontinuation trial (RDT) of tivozanib (AV-951) versus placebo in patients with renal cell carcinoma (RCC). ASCO Meeting Abstr 2011;29(15 Suppl):4550
35. Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: Results from a phase III randomized, open-label, multicenter trial. ASCO Meeting Abstr 2012;30(15 Suppl):4501
36. Kabbinavar FF, Srinivas S, Hauke RJ, et al. Results from a phase I trial of tivozanib (AV-951) combined with temsirolimus therapy in patients (pts) with renal cell carcinoma (RCC). ASCO Meeting Abstr 2011;29(15 Suppl):4549
37. Rini BI, Cohen DP, Lu DR, et al. Hypertension as a biomarker of efficacy in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 2011;103(9):763-73
38. AVEO Pharmaceuticals Press Release: aveo Reports Second Quarter 2012 Financial Results. Available from: http://investor.aveopharma.com/phoenix. zhtml?c=219651&p=irol-newsArticle&ID=1721417&highlight= [Last accessed 11 August 2012]
39. Pfizer Press Release: Pfizer Provides Topline Results From Phase 3 Study Of Ti ® T onsel As Second-Line reatment In Advanced Renal Cell Carcinoma (RCC). Available from: http://www.pfizer.com/news/press-releases/pfizer-press- release. jsp?guid=20120515006852en& source=RSS-2011&page=2 [Last accessed 11 August 2012]
40. Halabi S, Rini BI, Stadler WM, Small EJ. Use of progression-free survival (PFS) to predict overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol (Meeting Abstracts) 2010;28(15 Suppl):4525
41. Montero AJ, Vogel C. Fighting fire with fire: rekindling the bevacizumab debate. N Engl J Med 2012;366(4):374-5
42. Robinson MO, Lin J, Feng B, et al. Correlation of a tivozanib response biomarker identified in a preclinical model with clinical activity in a phase II study in renal cell carcinoma (RCC). ASCO Meeting Abstr 2010;28(15 Suppl):e13564
43. Hutson TE, Rathmell K, Hudes GR et al. A phase II biomarker assessment of tivozanib in oncology (BATON) trial in patients (pts) with advanced renal cell carcinoma (RCC). ASCO Meeting Abstr 2012;30(15 Suppl):TPS4686
44. DePrimo S, Bello C, Smeraglia J, et al. 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 2007;5(1):32
45. Ilias-Khan NA, Khakoo AY, Tannir NM. A clinical and biological profile to predict risk of development of hypertension in patients with non-clear cell renal cell carcinoma treated with sunitinib. J Clin Oncol (Meeting Abstracts) 2010;28(15 Suppl):4601
46. Feldman DR, Baum MS, Ginsberg MS, et al. Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27(9):1432-9
47. Socinski MA, Scappaticci FA, Samant M, et al. Safety and efficacy of combining sunitinib with bevacizumab + paclitaxel/carboplatin in non-small cell lung cancer. J Thorac Oncol 2010;5(3):354-60
48. Patel PH, Senico PL, Curiel RE, Motzer RJ. Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma. Clin Genitourin Cancer 2009;7(1):24-7
49. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004;64(19):7099-109