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Originally published as JCO Early Release 10.1200/JCO.2005.06.124 on December 21 2004

Journal of Clinical Oncology, Vol 23, No 5 (February 10), 2005: pp. 965-972
© 2005 American Society of Clinical Oncology.
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Phase I Clinical and Pharmacokinetic Study of the Novel Raf Kinase and Vascular Endothelial Growth Factor Receptor Inhibitor BAY 43-9006 in Patients With Advanced Refractory Solid Tumors

Dirk Strumberg, Heike Richly, Ralf A. Hilger, Norbert Schleucher, Sonke Korfee, Mitra Tewes, Markus Faghih, Erich Brendel, Dimitris Voliotis, Claus G. Haase, Brian Schwartz, Ahmad Awada, Rudolf Voigtmann, Max E. Scheulen, Siegfried Seeber

From the Department of Internal Medicine and Medical Oncology, West German Cancer Center, University Medical School of Essen, Essen; Department of Hematology and Medical Oncology, University of Bochum, Herne; Bayer Healthcare, Pharma Research Center, Wuppertal, Germany; Bayer Pharmaceuticals Corporation, West Haven, CT; and Jules Bordet Institute, Brussels, Belgium

Address reprint requests to Dirk Strumberg, MD, Department of Hematology and Medical Oncology, Marienhospital Herne, University of Bochum, Hölkeskampring 40, 44 621 Herne, Germany; e-mail: dirk.strumberg{at}uni-essen.de.

PURPOSE: BAY 43-9006 is a novel dual-action Raf kinase and vascular endothelial growth factor receptor inhibitor that inhibits tumor cell proliferation and angiogenesis. This study established the safety and pharmacokinetics of BAY 43-9006 in 69 patients with advanced refractory solid tumors.

PATIENTS AND METHODS: BAY 43-9006 (50 to 800 mg) was administered once or twice daily on a varying weekly schedule. Pharmacokinetic sampling was performed in all patients; preliminary tumor response was also assessed. The effect of BAY 43-9006 on phorbol myristate acetate–stimulated ERK phosphorylation in peripheral blood lymphocytes was studied using flow cytometry.

RESULTS: Mild to moderate diarrhea was the most common (55%) treatment-related adverse event. The maximum-tolerated dose was 400 mg bid continuous. Dose-limiting toxicities were grade 3 diarrhea and fatigue at 800 mg bid, and grade 3 skin toxicity at 600 mg bid. BAY 43-9006 pharmacokinetics were highly variable for single and multiple dosing, and toxicity did not appear to be dose dependent. Significant decreases of phorbol myristate acetate–stimulated ERK phosphorylation (P < .01) were identified at doses ≥ 200 mg bid continuous. Forty-five patients were assessable for efficacy; one patient had a partial response (hepatocellular carcinoma at 400 mg bid continuous), 25 patients had stable disease, with eight lasting > 6 months and five for >12 months. Eighteen patients had progressive disease, and tumor response could not be evaluated in one patient.

CONCLUSION: Oral BAY 43-9006 was well tolerated and appeared to provide some clinical benefits. Based on the results of this study, BAY 43-9006 at 400 mg bid continuous is recommended for ongoing and future studies.

Supported by Bayer Pharmaceuticals Corporation.

Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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Tyrosine Kinase Inhibitors of Vascular Endothelial Growth Factor Receptors in Clinical Trials: Current Status and Future Directions
Oncologist, July 1, 2006; 11(7): 753 - 764.
[Abstract] [Full Text] [PDF]

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 BloodHome page
T. Luft, E. Rodionova, E. Maraskovsky, M. Kirsch, M. Hess, C. Buchholtz, M. Goerner, M. Schnurr, R. Skoda, and A. D. Ho
Adaptive functional differentiation of dendritic cells: integrating the network of extra- and intracellular signals
Blood, June 15, 2006; 107(12): 4763 - 4769.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. J. Ratain, T. Eisen, W. M. Stadler, K. T. Flaherty, S. B. Kaye, G. L. Rosner, M. Gore, A. A. Desai, A. Patnaik, H. Q. Xiong, et al.
Phase II Placebo-Controlled Randomized Discontinuation Trial of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
J. Clin. Oncol., June 1, 2006; 24(16): 2505 - 2512.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
H. Richly, B. F. Henning, P. Kupsch, K. Passarge, M. Grubert, R. A. Hilger, O. Christensen, E. Brendel, B. Schwartz, M. Ludwig, et al.
Results of a Phase I trial of sorafenib (BAY 43-9006) in combination with doxorubicin in patients with refractory solid tumors
Ann. Onc., May 1, 2006; 17(5): 866 - 873.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
F. G. Haluska, H. Tsao, H. Wu, F. S. Haluska, A. Lazar, and V. Goel
Genetic alterations in signaling pathways in melanoma.
Clin. Cancer Res., April 1, 2006; 12(7): 2301s - 2307s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Salvatore, V. De Falco, P. Salerno, T. C. Nappi, S. Pepe, G. Troncone, F. Carlomagno, R. M. Melillo, S. M. Wilhelm, and M. Santoro
BRAF Is a Therapeutic Target in Aggressive Thyroid Carcinoma
Clin. Cancer Res., March 1, 2006; 12(5): 1623 - 1629.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. A. Reardon and P. Y. Wen
Therapeutic advances in the treatment of glioblastoma: rationale and potential role of targeted agents.
Oncologist, February 1, 2006; 11(2): 152 - 164.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
K. P. Hoeflich, D. C. Gray, M. T. Eby, J. Y. Tien, L. Wong, J. Bower, A. Gogineni, J. Zha, M. J. Cole, H. M. Stern, et al.
Oncogenic BRAF Is Required for Tumor Growth and Maintenance in Melanoma Models
Cancer Res., January 15, 2006; 66(2): 999 - 1006.
[Abstract] [Full Text] [PDF]

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 JCOHome page
W. M. Stadler
New Targets, Therapies, and Toxicities: Lessons to Be Learned
J. Clin. Oncol., January 1, 2006; 24(1): 4 - 5.
[Full Text] [PDF]

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 Clin. Cancer Res.Home page
L. L. Siu, A. Awada, C. H. Takimoto, M. Piccart, B. Schwartz, T. Giannaris, C. Lathia, O. Petrenciuc, and M. J. Moore
Phase I Trial of Sorafenib and Gemcitabine in Advanced Solid Tumors with an Expanded Cohort in Advanced Pancreatic Cancer
Clin. Cancer Res., January 1, 2006; 12(1): 144 - 151.
[Abstract] [Full Text] [PDF]

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 J. Pharmacol. Exp. Ther.Home page
A. Arora and E. M. Scholar
Role of Tyrosine Kinase Inhibitors in Cancer Therapy
J. Pharmacol. Exp. Ther., December 1, 2005; 315(3): 971 - 979.
[Abstract] [Full Text] [PDF]

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 ASH ANNUAL MEETING ABSTRACTSHome page
J. W. Smith, H. Powell, A. Tefferi, S. H. Kaufmann, T. Lasho, D. Loegerling, M. Galvez, and R. Mesa
Evaluation of the In Vitro Activity of the Multikinase Inhibitor BAY 43-9006 (Sorafenib) in Primary Cells from Patients with Myelofibrosis with Myeloid Metaplasia (MMM).
Blood (ASH Annual Meeting Abstracts), November 16, 2005; 106(11): 4943 - 4943.
[Abstract]

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 JCOHome page
R. D. Loberg, C. J. Logothetis, E. T. Keller, and K. J. Pienta
Pathogenesis and Treatment of Prostate Cancer Bone Metastases: Targeting the Lethal Phenotype
J. Clin. Oncol., November 10, 2005; 23(32): 8232 - 8241.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
M. Moore, H. W. Hirte, L. Siu, A. Oza, S. J. Hotte, O. Petrenciuc, F. Cihon, C. Lathia, and B. Schwartz
Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors
Ann. Onc., October 1, 2005; 16(10): 1688 - 1694.
[Abstract] [Full Text] [PDF]

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 CA Cancer J ClinHome page
K. J. Pienta and D. C. Smith
Advances in Prostate Cancer Chemotherapy: A New Era Begins
CA Cancer J Clin, September 1, 2005; 55(5): 300 - 318.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. A. Adjei and M. Hidalgo
Intracellular Signal Transduction Pathway Proteins As Targets for Cancer Therapy
J. Clin. Oncol., August 10, 2005; 23(23): 5386 - 5403.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. J. Cohen, R. B. Cohen, and N. J. Meropol
Targeting Signal Transduction Pathways in Colorectal Cancer--More Than Skin Deep
J. Clin. Oncol., August 10, 2005; 23(23): 5374 - 5385.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J.-C. Barbare, O. Bouche, F. Bonnetain, J.-L. Raoul, P. Rougier, A. Abergel, V. Boige, B. Denis, A. Blanchi, A. Pariente, et al.
Randomized Controlled Trial of Tamoxifen in Advanced Hepatocellular Carcinoma
J. Clin. Oncol., July 1, 2005; 23(19): 4338 - 4346.
[Abstract] [Full Text] [PDF]


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