BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)
NCT00101413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2013-10-30
Summary
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.
* If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
* If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
* If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.
Conditions
- Cancer
- Carcinoma, Non-Small Cell Lung
Interventions
- DRUG
-
Sorafenib (Nexavar, BAY43-9006)
BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.
Sponsors & Collaborators
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Primary Completion
- 2005-06-30
- Completion
- 2008-04-30
Countries
- United States
- Germany
Study Locations
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