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Sponsored by: |
Bayer |
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00586105 |
A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma
Condition | Intervention | Phase |
Carcinoma, Renal Cell |
Drug: Nexavar (Sorafenib, BAY43-9006) |
Phase III |
ChemIDplus related topics: | Sorafenib Sorafenib tosylate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Uncontrolled Study of Sorafenib in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma |
Enrollment: | 40 |
Study Start Date: | December 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
Multikinase Inhibitor
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Amylase and lipase < 1.5 x the upper limit of normal.
Exclusion Criteria:
Excluded concomitant medications:
China | |||||
Beijing, China, 100021 | |||||
Shanghai, China, 200127 | |||||
shanghai, China, 200030 | |||||
China, Jiangsu | |||||
Nanjing, Jiangsu, China, 210002 | |||||
Taiwan | |||||
Tainan, Taiwan, 70428 | |||||
Taipei, Taiwan | |||||
Taoyuan, Taiwan, 333 | |||||
Taipei, Taiwan, 100 |
Bayer |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 11559 |
First Received: | December 21, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00586105 |
Health Authority: | China: Ministry of Health; Taiwan: Department of Health; United States: Institutional Review Board |
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