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Title: Phase 2 trial of linifanib (ABT-869) in patients with advanced non-small cell lung cancer
Authors: Tan, E.-H.
Goss, G.D.
Salgia, R.
Besse, B.
Gandara, D.R.
Hanna, N.H.
Yang, J.C.-H.
Thertulien, R.
Wertheim, M.
Mazieres, J.
Hensing, T.
Lee, C.
Gupta, N.
Pradhan, R.
Qian, J.
Qin, Q.
Scappaticci, F.A.
Ricker, J.L.
Carlson, D.M.
Soo, R.A. 
Keywords: Angiogenesis
Linifanib (ABT-869)
Issue Date: Aug-2011
Citation: Tan, E.-H., Goss, G.D., Salgia, R., Besse, B., Gandara, D.R., Hanna, N.H., Yang, J.C.-H., Thertulien, R., Wertheim, M., Mazieres, J., Hensing, T., Lee, C., Gupta, N., Pradhan, R., Qian, J., Qin, Q., Scappaticci, F.A., Ricker, J.L., Carlson, D.M., Soo, R.A. (2011-08). Phase 2 trial of linifanib (ABT-869) in patients with advanced non-small cell lung cancer. Journal of Thoracic Oncology 6 (8) : 1418-1425. ScholarBank@NUS Repository.
Abstract: This study assessed activity and safety of linifanib (ABT-869), a selective inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, in patients with locally advanced or metastatic non-small cell lung cancer. Methods: In this open-label trial (NCT00517790), patients who received one to two prior lines of systemic therapy were randomized to oral linifanib 0.10 mg/kg (low dose) or 0.25 mg/kg (high dose) once daily. Tumor responses were assessed by independent central imaging review every 8 weeks. The primary end point was progression-free rate at 16 weeks. Secondary end points included objective response rate, time to progression, progression-free survival, and overall survival. Safety was also assessed. Results: Between August 2007 and October 2008, 139 patients were enrolled; 60% had two or more prior regimens, and 88% had nonsquamous cell carcinoma. The objective response rate (low dose and high dose) was 5.0% (3.1 and 6.8%), progression-free rate at 16 weeks was 33.1% (32.3 and 33.8%), median time to progression was 3.6 months (3.6 and 3.7 months), median progression-free survival was 3.6 months (3.5 and 3.6 months), and median overall survival was 9.0 months (10.0 and 8.3 months). The most common linifanib-related adverse events were fatigue (42%), decreased appetite (38%), hypertension (37%), diarrhea (32%), nausea (27%), palmar-plantar erythrodysesthesia (24%), and proteinuria (22%). These events were more common in the high-dose group. The most common linifanib-related grade 3 or 4 adverse event was hypertension (14%). Conclusions: Linifanib is active in advanced non-small cell lung cancer as second- or third-line therapy. Increased adverse event rates were observed at the high dose of linifanib. Copyright © 2011 by the International Association for the Study of Lung Cancer.
Source Title: Journal of Thoracic Oncology
ISSN: 15560864
DOI: 10.1097/JTO.0b013e318220c93e
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