Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib
NCT00352859 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2014-12-30
Summary
The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.
Conditions
- Carcinoma, Renal Cell
Interventions
- DRUG
-
Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon
Continue sorafenib with addition of gemcitabine or interferon
- DRUG
-
Gemcitabine or Interferon (only)
Discontinue Sorafenib and receive Gemcitabine or Interferon only
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-08-31
- Completion
- 2006-11-30
Countries
- United States
Study Locations
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