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https://hdl.handle.net/2440/112788
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dc.contributor.author | Jonker, D. | - |
dc.contributor.author | Rosen, L. | - |
dc.contributor.author | Sawyer, M. | - |
dc.contributor.author | de Braud, F. | - |
dc.contributor.author | Wilding, G. | - |
dc.contributor.author | Sweeney, C. | - |
dc.contributor.author | Jayson, G. | - |
dc.contributor.author | McArthur, G. | - |
dc.contributor.author | Rustin, G. | - |
dc.contributor.author | Goss, G. | - |
dc.contributor.author | Kantor, J. | - |
dc.contributor.author | Velasquez, L. | - |
dc.contributor.author | Syed, S. | - |
dc.contributor.author | Mokliatchouk, O. | - |
dc.contributor.author | Feltquate, D. | - |
dc.contributor.author | Kollia, G. | - |
dc.contributor.author | Nuyten, D. | - |
dc.contributor.author | Galbraith, S. | - |
dc.date.issued | 2011 | - |
dc.identifier.citation | Annals of Oncology, 2011; 22(6):1413-1419 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.issn | 1569-8041 | - |
dc.identifier.uri | http://hdl.handle.net/2440/112788 | - |
dc.description.abstract | Background: This study was designed to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of brivanib in patients with advanced/metastatic solid tumors. Patients and methods: Ninety patients enrolled in this two-part, phase I open-label study of oral brivanib alaninate. The primary objectives of this study were (in part A) dose-limiting toxicity, maximum tolerated dose (MTD) and the lowest biologically active dose level and (in part B) the optimal dose/dose range. The secondary objectives of this study were preliminary evidence of antitumor activity, PK and PD. Results: Across part A (open-label dose escalation and MTD) and part B (open-label dose optimization), 68 patients received brivanib alaninate. Brivanib demonstrated a manageable toxicity profile at doses of 180–800 mg. Most toxic effects were mild. Systemic exposure of the active moiety brivanib increased linearly ≤1000 mg/day. The MTD was 800 mg/day. Forty-four patients were treated at the MTD: 20 with 800 mg continuously, 11 with 800 mg intermittently and 13 with 400 mg b.i.d. doses. Partial responses were confirmed in two patients receiving brivanib ≥600 mg. Dynamic contrast-enhanced magnetic resonance imaging demonstrated statistically significant decreases in parameters reflecting tumor vascularity and permeability after multiple doses in the 800-mg continuous q.d. and 400-mg b.i.d. dose cohorts. Conclusion: In patients with advanced/metastatic cancer, brivanib demonstrates promising antiangiogenic and antitumor activity and manageable toxicity at doses ≤800 mg orally q.d., the recommended phase II study dose. | - |
dc.description.statementofresponsibility | D. J. Jonker, L. S. Rosen, M. B. Sawyer, F. de Braud, G. Wilding, C. J. Sweeney, G. C. Jayson, G. A. McArthur, G. Rustin, G. Goss, J. Kantor, L. Velasquez, S. Syed, O. Mokliatchouk, D. M. Feltquate, G. Kollia, D. S. A. Nuyten, S. Galbraith | - |
dc.language.iso | en | - |
dc.publisher | Oxford University Press | - |
dc.rights | © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. | - |
dc.source.uri | http://dx.doi.org/10.1093/annonc/mdq599 | - |
dc.subject | Antiangiogenesis; brivanib; fibroblast growth factor; vascular endothelial growth factor | - |
dc.title | A phase I study to determine the safety, pharmacokinetics and pharmacodynamics of a dual VEGFR and FGFR inhibitor, brivanib, in patients with advanced or metastatic solid tumors | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1093/annonc/mdq599 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Sweeney, C. [0000-0002-0398-6018] | - |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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