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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00259129 |
This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg tablets) in cancer patients. The primary objective of the study is to evaluate the effect of sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients
Condition | Intervention | Phase |
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Cancer |
Drug: BAY 43-9006 (sorafenib) |
Phase I |
Study Type: | Observational |
Study Design: | Prospective |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Andrew Wolanski, NP 617-632-6623 awolanski@partners.org | |
Contact: Leonard J. Appleman | |
United States, Texas | |
The Institute for Drug Development | Recruiting |
San Antonio, Texas, United States, 78229-4427 | |
Contact: Epp Goodwin 210-616-5768 egoodwin@ctrc.net | |
Contact: Anthony Tolcher, MD |
Study ID Numbers: | 100561 |
Study First Received: | November 28, 2005 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00259129 |
Health Authority: | United States: Food and Drug Administration |
Sorafenib |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |