Phase 2 trial of linifanib (ABT-869) in patients with advanced non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 6, Issue 8, 2011, Pages 1418-1425

  Tan, Eng Huat ^a   Goss, Glenwood D ^b   Salgia, Ravi ^c   Besse, Benjamin ^d   Gandara, David R ^e   Hanna, Nasser H ^f   Yang, James Chih Hsin ^g   Thertulien, Raymond ^h   Wertheim, Michael ⁱ   Mazieres, Julien ^j   Hensing, Thomas ^k   Lee, Christa ^l   Gupta, Neeraj ^l   Pradhan, Rajendra ^l   Qian, Jiang ^l   Qin, Qin ^l   Scappaticci, Frank A ^m   Ricker, Justin L ^l   Carlson, Dawn M ^l   Soo, Ross A ⁿ  

^a DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^b OTTAWA REGIONAL CANCER CENTRE   (Canada)

^c UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^h Cancer Centers of North Carolina   (United States)

ⁱ Hematology Oncology Associates of Treasure Coast   (United States)

^j CHU RANGUEIL   (France)

^k Kellog Cancer Center   (United States)

^l ABBOTT LABORATORIES   (United States)

^m GENENTECH INC   (United States)

ⁿ NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

more..

Author keywords

Angiogenesis; Linifanib (ABT 869); NSCLC; PDGFR; VEGFR

Indexed keywords

LINIFANIB;

ADULT; ADVANCED CANCER; APPETITE DISORDER; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG ERUPTION; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOTHYROIDISM; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; NAUSEA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; REVIEW; TREATMENT RESPONSE;

EID: 80051801904     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e318220c93e     Document Type: Article

References (43)

1. International Agency for Research on Cancer and World Health Organization. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide in 2008. Available at: .
2. Herbst RS, Heymach JV, Lippman SM. Lung cancer. N Engl J Med 2008;359:1367-1380.
3. Gridelli C, Langer C, Maione P, et al. Lung cancer in the elderly. J Clin Oncol 2007;25:1898-1907. (Pubitemid 46854424)
4. Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med 2004;350:379-392. (Pubitemid 38101633)
5. Herbst RS, Onn A, Sandler A. Angiogenesis and lung cancer: prognostic and therapeutic implications. J Clin Oncol 2005;23:3243-3256. (Pubitemid 46211349)
6. O'Byrne KJ, Koukourakis MI, Giatromanolaki A, et al. Vascular endothelial growth factor, platelet-derived endothelial cell growth factor and angiogenesis in non-small-cell lung cancer. Br J Cancer 2000;82:1427-1432. (Pubitemid 30175909)
7. Giaccone G. The potential of antiangiogenic therapy in non-small cell lung cancer. Clin Cancer Res 2007;13:1961-1970. (Pubitemid 46649861)
8. 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: 2542-2550. (Pubitemid 44917502)
9. Reck M, von Pawel J, Zatloukal P, et al. Overall survival with cisplatingemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol 2010;21:1804-1809.
10. Scagliotti G, Novello S, von Pawel J, et al. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol 2010;28:1835-1842.
11. Pal SK, Figlin RA, Reckamp K. Targeted therapies for non-small cell lung cancer: an evolving landscape. Mol Cancer Ther 2010;9:1931-1944.
12. Lee J, Hirsh V, Park K, et al. Vandetanib versus placebo in patients with advanced non-small cell lung cancer (NSCLC) after prior therapy with an EGFR tyrosine kinase inhibitor (TKI): a randomized, double-blind phase III trial (ZEPHYR). J Clin Oncol (Meeting Abstracts) 2010; 28(Suppl 15):abstract 7525.
13. Natale RB, Thongprasert S, Greco FA, et al. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 2011;29:1059-1066.
14. de Boer RH, ArrietaÖ , Yang CH, et al. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol 2011;29:1067-1074.
15. Herbst RS, Sun Y, Eberhardt WE, et al. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol 2010;11:619-626.
16. National Institutes of Health: a phase III randomized, double-blind, placebo controlled trial comparing the efficacy of gemcitabine, cisplatin and sorafenib to gemcitabine, cisplatin and placebo in first-line treatment of patients with stage IIIb with effusion and stage IV non-small cell lung cancer (NSCLC) (NEXUS). Protocol: (NCT00449033). Available at: .
17. National Institutes of Health: a 3rd/4th line placebo-controlled trial of sorafenib in patients with predominantly non squamous non-small cell lung cancer (NSCLC). (MISSION). Protocol: (NCT00863746). Available at: .
18. National Institutes of Health: sunitinib as maintenance therapy in treating patients with stage III stage IV non-small cell lung cancer previously treated with combination chemotherapy. Protocol: (NCT00693992). Available at: .
19. National Institutes of Health: cediranib, paclitaxel, and carboplatin in treating patients with stage IIIB or stage IV non-small cell lung cancer. Protocol: (NCT00795340). Available at: .
20. National Institutes of Health: MONET1-MOtesanib NSCLC efficacy and tolerability study. Protocol: (NCT00460317). Available at: .
21. National Institutes of Health: Lume lung 2: BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLC. Protocol: (NCT00806819). Available at: .
22. National Institutes of Health: LUME-lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancer. Protocol: (NCT00805194). Available at: .
23. Dai Y, Hartandi K, Ji Z, et al. Discovery of N-(4-(3-amino-1H-indazol- 4-yl)phenyl)-N-(2-fluoro-5-methylphenyl)urea (ABT-869), a 3-aminoindazole- based orally active multitargeted receptor tyrosine kinase inhibitor. J Med Chem 2007;50:1584-1597. (Pubitemid 46564379)
24. Albert DH, Tapang P, Magoc TJ, et al. Preclinical activity of ABT-869, a multitargeted receptor tyrosine kinase inhibitor. Mol Cancer Ther 2006;5:995-1006. (Pubitemid 43724600)
25. Guo J, Marcotte PA, McCall JO, et al. Inhibition of phosphorylation of the colony-stimulating factor-1 receptor (c-Fms) tyrosine kinase in transfected cells by ABT-869 and other tyrosine kinase inhibitors. Mol Cancer Ther 2006;5:1007-1013. (Pubitemid 43724601)
26. Shankar DB, Li J, Tapang P, et al. ABT-869, a multitargeted receptor tyrosine kinase inhibitor: inhibition of FLT3 phosphorylation and signaling in acute myeloid leukemia. Blood 2007;109:3400-3408. (Pubitemid 46572529)
27. Zhou J, Khng J, Jasinghe VJ, et al. In vivo activity of ABT-869, a multi-target kinase inhibitor, against acute myeloid leukemia with wildtype FLT3 receptor. Leuk Res 2008;32:1091-1100.
28. Wong CI, Koh TS, Soo R, et al. Phase I and biomarker study of ABT-869, a multiple receptor tyrosine kinase inhibitor, in patients with refractory solid malignancies. J Clin Oncol 2009;27:4718-4726.
29. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216. (Pubitemid 30099779)
30. NCI. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). 2006. Available at: http://ctep.cancer.gov/. Accessed July 2010.
31. Azzoli CG, Baker S Jr, Temin S, et al. American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2009;27:6251-6266.
32. Shankar LK, Sullivan DC. Functional imaging in lung cancer. J Clin Oncol 2005;23:3203-3211. (Pubitemid 46211344)
33. Ahmed FE, Vos PW, Holbert D. Modeling survival in colon cancer: a methodological review. Mol Cancer 2007;6:15.
34. Cohen MH, Gootenberg J, Keegen P, et al. FDA drug approval summary: bevacizumab (Avastin) plus carboplatin and paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer. Oncologist 2007;12:713-718. (Pubitemid 47036205)
35. Zhou J, Goh BC, Albert DH, et al. ABT-869, a promising multi-targeted tyrosine kinase inhibitor: from bench to bedside. J Hematol Oncol 2009;2:33.
36. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353: 123-132. (Pubitemid 41058344)
37. Natale RB, Bodkin D, Govindan R, et al. Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: results from a twopart, double-blind, randomized phase II study. J Clin Oncol 2009;27: 2523-2529.
38. Schiller JH, Larson T, Ou SH, et al. Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: results from a phase II study. J Clin Oncol 2009;27:3836-3841.
39. Blumenschein GR Jr, Gatzemeier U, Fossella F, et al. Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non-small-cell lung cancer. J Clin Oncol 2009;27:4274-4280.
40. Socinski MA, Novello S, Brahmer JR, et al. Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. J Clin Oncol 2008;26:650-656. (Pubitemid 351264362)
41. Gitlitz BJ, Moon J, Glisson BS, et al. Sorafenib in platinum-treated patients with extensive stage small cell lung cancer: a Southwest Oncology Group (SWOG 0435) phase II trial. J Thorac Oncol 2010;5: 1835-1840.
42. Ramalingam SS, Belani CP, Mack PC, et al. Phase II study of cediranib (AZD 2171), an inhibitor of the vascular endothelial growth factor receptor, for second-line therapy of small cell lung cancer (National Cancer Institute #7097). J Thorac Oncol 2010;5:1279-1284.
43. National Institutes of Health: a phase 2 randomized, placebo-controlled, double-blind study of carboplatin/paclitaxel in combination with ABT- 869 versus carboplatin/paclitaxel alone in subjects with advanced or metastatic non-small cell lung cancer (NSCLC) as first-line treatment. Protocol: (NCT00716534). Available at: .