The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours
Open accessAbstract
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.
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Cites
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Therasse, P., Arbuck, S. G., Eisenhauer, E. A., Wanders, J., Kaplan, R. S., Rubinstein, L., Verweij, J., Van Glabbeke, M., van Oosterom, A. T., Christian, M. C., et al. (2000) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/92.3.205 · Cited by 15,660
Mutations of the BRAF gene in human cancer
Davies, H., Bignell, G. R., Cox, C., Stephens, P., Edkins, S., Clegg, S., Teague, J., Woffendin, H., Garnett, M. J., Bottomley, W., et al. (2002) · Nature · doi:10.1038/nature00766 · Cited by 10,674
RAF/RAS oncogenes and mismatch-repair status
Rajagopalan, H., Bardelli, A., Lengauer, C., Kinzler, K. W., Vogelstein, B., & Velculescu, V. E. (2002) · Nature · doi:10.1038/418934a · Cited by 1,224 · cited 1×
“BAY 43-9006 also slowed tumour growth of ovarian cancer derived from the SKOV-3 cell line, which contains wild-type K-Ras but overexpresses epidermal growth factor and HER-2 receptors (Gianpaolo-Ostravage et al, 2001; Lyons et al, 2001).”
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Cited by
Targeting the Raf-MEK-ERK mitogen-activated protein kinase cascade for the treatment of cancer
Roberts, P. J., & Der, C. J. (2007) · Oncogene · doi:10.1038/sj.onc.1210422 · Cited by 2,788
Dixon, S. J., Patel, D. N., Welsch, M., Skouta, R., Lee, E. D., Hayano, M., Thomas, A. G., Gleason, C. E., Tatonetti, N. P., Slusher, B. S., et al. (2014) · eLife · doi:10.7554/elife.02523 · Cited by 2,088
Possible molecular mechanisms involved in the toxicity of angiogenesis inhibition
Verheul, H. M. W., & Pinedo, H. M. (2007) · Nature Reviews Cancer · doi:10.1038/nrc2152 · Cited by 503
Targeting the HIF2–VEGF axis in renal cell carcinoma
Choueiri, T. K., & Kaelin, W. G. (2020) · Nature Medicine · doi:10.1038/s41591-020-1093-z · Cited by 477
Motzer, R. J., Agarwal, N., Beard, C., Bolger, G. B., Boston, B., Carducci, M. A., Choueiri, T. K., Figlin, R. A., Fishman, M., Hancock, S. L., et al. (2009) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2009.0043 · Cited by 470
Metadata
- 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.
- Venue
- British Journal of Cancer
- Published
- 2005-05
- Volume
- 92
- Issue
- 10
- Pages
- 1855-1861
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- OpenAlex
- W2018348203
- Cited by
- 339
- References
- 3
- FWCI
- 12.91
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. https://app.cochat.ai/papers/10.1038/sj.bjc.6602584
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- Awada, A., Hendlisz, A., Gil, T., Bartholomeus, S., Mano, M., de Valeriola, D., Strumberg, D., Brendel, E., Haase, C. G., Schwartz, B., & Piccart, M. (2005). Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. British Journal of Cancer. https://doi.org/10.1038/sj.bjc.6602584
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
