An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Cancer
Both
Renal Cell Cancer
Trial Information
An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- metastatic renal cell cancer of predominantly clear cell type;
- >=1 measurable lesion.
Exclusion Criteria:
- prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for
metastatic renal cell cancer;
- ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily
treatment with aspirin (>325mg/day);
- clinically significant cardiovascular disease.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median progression-free survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Germany: Landesamt fur Gesundheit und Soziales Berlin
Study ID:
ML19983
NCT ID:
NCT00520403
Start Date:
September 2007
Completion Date:
March 2010
Related Keywords:
- Renal Cell Cancer
- Carcinoma, Renal Cell
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