Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors

CME Activity Information
Release Date:	April 30, 2007
Most Recent Review:	April 30, 2007*
Most Recent Update:	April 30, 2007
Date Credit Expires:	April 30, 2009
Time to Complete:	1 hour
Medium:	Internet Online
*Click here to learn more about our review process.

Instructions for Participation

1. Read the following information before beginning the educational activity and click the "Take this course" link at the bottom of the page
2. Study the educational activity
3. Complete the CME quiz and evaluation
4. After successful completion of the CME quiz and evaluation, you will receive the credit or participation certificate

   *The CME quiz and evaluation must be completed by April 30, 2009, in order to receive the credit or participation certificate.

1. Describe the mechanisms of action of sorafenib.
2. Discuss the safety and toxicity data from phase I trials of sorafenib.
3. Evaluate phase I and II trials of sorafenib with activity data.
4. Discuss future areas for research in the development of this drug.

All information is submitted and reviewed and found to be scientifically rigorous, based on the best available evidence, fair and balanced, and free of commercial bias. All the recommendations involving clinical medicine in this CME activity are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation conforms to the generally accepted standards of experimental design, data collection and analysis.

Any potential conflicts of interests are resolved via The Oncologist's anonymous peer review process: http://theoncologist.alphamedpress.org/misc/ifora.shtml. All manuscripts are reviewed by the Editorial Board with ad hoc assistance from two or more external experts in the field. All final publication decisions are made by the Editorial Board. The acceptance of a manuscript is based on its originality and importance to the field as assessed by the Editors.

Credentials: Department of Hematology and Medical Oncology, Marienhospital Herne, University Medical School of Bochum, Herne, Germany. Telephone: 49-2323-499-5252; Fax: 49-2323-499-1578; E-mail: a.mathijssen{at}erasmusmc.nl.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of BAY43-9006 (sorafenib), manufactured by Bayer/Onyx Pharmaceuticals, as a study drug in various renal cell carcinoma trials.

Jeffrey W. Clark, M.D.

Credentials: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of sorafenib, manufactured by Bayer, in the phase I evaluation of various tumors.

Ahmad Awada, M.D.

Credentials: Jules Bordet Institute, Brussels, Belgium.
Disclosures: The author has indicated no relevant commercial relationships.

Malcolm J. Moore, M.D.

Credentials: Princess Margaret Hospital, Toronto, Ontario, Canada.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of sorafenib, manufactured by Bayer, in a variety of solid tumors.

Heike Richly, M.D.

Credentials: Department of Hematology and Medical Oncology, Marienhospital Herne, University Medical School of Bochum, Herne, Germany.
Disclosures: The author has indicated that they discuss the unlabeled, investigational, or alternative use(s) of the study drug BAY43-9006, manufactured by Bayer, for chemotherapy.

Alain Hendlisz, M.D.

Credentials: Jules Bordet Institute, Brussels, Belgium.
Disclosures: The author has indicated that they discuss the unlabeled, investigational of alternative use(s) of sorafenib, manufactured by Bayer, as an anticancer drug.

Hal W. Hirte, M.D.

Credentials: Juravinski Cancer Center, Hamilton, Ontario, Canada.
Disclosures: The author has indicated that they discuss the investigational use of BAY43-9006 manufactured by Bayer.

Joseph P. Eder, M.D.

Credentials: Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Disclosures: The author has indicated no relevant commercial relationships.

Heinz-Joseph Lenz, M.D.

Credentials: University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, California, USA.
Disclosures: The author has received clinical trial support, served as a speaker and consultant for Bristol-Myers Squibb and sanofi-aventis.

Brian Schwartz, M.D.

Credentials: Bayer Pharmaceuticals Corporation, West Haven, Connecticut, USA.
Disclosures: The author was formerly employed by Bayer and was the clinical leader responsible for the development of sorafenib. His current affiliation is Ziopharm Oncology.

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