Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/53934
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Type: | Journal article |
Title: | Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours |
Author: | Price, T. Lipton, L. McGreivy, J. McCoy, S. Sun, Y. Rosenthal, M. |
Citation: | British Journal of Cancer, 2008; 99(9):1387-1394 |
Publisher: | Nature Publishing Group |
Issue Date: | 2008 |
ISSN: | 0007-0920 1532-1827 |
Statement of Responsibility: | TJ Price, L Lipton, J McGreivy, S McCoy, Y-N Sun and MA Rosenthal |
Abstract: | The aim of this open-label phase 1b study was to assess the safety and pharmacokinetics of motesanib in combination with gemcitabine in patients with advanced solid tumours. Eligible patients with histologically or cytologically documented solid tumours or lymphoma were enroled in three sequential, dose-escalating cohorts to receive motesanib 50 mg once daily (QD), 75 mg two times daily (BID), or 125 mg QD in combination with gemcitabine (1000 mg m−2). The primary end point was the incidence of dose-limiting toxicities (DLTs). Twenty-six patients were enroled and received motesanib and gemcitabine. No DLTs occurred. The 75 mg BID cohort was discontinued early; therefore, 125 mg QD was the maximum target dose. Sixteen patients (62%) experienced motesanib-related adverse events, most commonly lethargy (n=6), diarrhoea (n=4), fatigue (n=3), headache (n=3), and nausea (n=3). The pharmacokinetics of motesanib and of gemcitabine were not markedly affected after combination therapy. The objective response rate was 4% (1 of 26), and 27% (7 of 26) of patients achieved stable disease. In conclusion, treatment with motesanib plus gemcitabine was well tolerated, with adverse event and pharmacokinetic profiles similar to that observed in monotherapy studies. |
Keywords: | advanced solid tumours angiogenesis gemcitabine lymphoma motesanib diphosphate pharmacokinetics |
Description: | Copyright © 2008 Cancer Research UK |
DOI: | 10.1038/sj.bjc.6604723 |
Published version: | http://dx.doi.org/10.1038/sj.bjc.6604723 |
Appears in Collections: | Aurora harvest 5 Medicine publications |
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hdl_53934.pdf | Published version | 154.41 kB | Adobe PDF | View/Open |
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