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- Title
Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours.
- Authors
Awada, A.; Hendlisz, A.; Gil, T.; Bartholomeus, S.; Mano, M.; de Valeriola, D.; Strumberg, D.; Brendel, E.; Haase, C. G.; Schwartz, B.; Piccart, M.
- Abstract
BAY 43-9006 is a novel dual-action Raf kinase and vascular endothelial growth factor receptor (VEGFR) inhibitor that targets tumour cell proliferation and tumour angiogenesis. This Phase I study was undertaken to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), pharmacokinetics, and tumour response profile of oral BAY 43-9006 in patients with advanced, refractory solid tumours. BAY 43-9006 was administered daily for repeated cycles of 21 days on/7 days off. A total of 44 patients were enrolled at doses from 50 to 800?mg b.i.d. Pharmacokinetic profiles of BAY 43-9006 in plasma were determined during the first treatment cycle. The most frequently reported adverse events over multiple cycles were gastrointestinal (75%), dermatologic (71%), constitutional (68%), pain (64%), or hepatic (61%) related. A MTD of 400?mg b.i.d. BAY 43-9006 was defined. BAY 43-9006 was absorbed rapidly; steady-state conditions were reached within 7 days. BAY 43-9006 exposure increased nonproportionally with increasing dose. In all, 32 patients were evaluated for tumour response: 15 patients showed tumour progression, 16 patients experienced stable disease (>6 months in eight patients), and one patient with renal cell carcinoma achieved a partial response. BAY 43-9006 given for 21 days with 7 days off treatment was safe, well tolerated, and showed antitumour activity.British Journal of Cancer (2005) 92, 1855-1861. doi:10.1038/sj.bjc.6602584 www.bjcancer.com Published online 3 May 2005
- Subjects
PHARMACOKINETICS; CANCER treatment; CANCER cells; CELL proliferation; NEOVASCULARIZATION; RENAL cancer
- Publication
British Journal of Cancer, 2005, Vol 92, Issue 10, p1855
- ISSN
0007-0920
- Publication type
Article
- DOI
10.1038/sj.bjc.6602584