A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Cancer
Both
Renal Cell Cancer
Trial Information
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Inclusion Criteria:
- adult patients;
- >=18 years of age;
- metastatic renal cell cancer (clear cell type);
- nephrectomy;
- absence of proteinuria.
Exclusion Criteria:
- prior systemic treatment for metastatic renal cell cancer;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to study treatment start;
- presence of brain metastases;
- ongoing need for full dose anticoagulants;
- uncontrolled hypertension;
- clinically significant cardiovascular disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall survival.\n
Outcome Time Frame:
Week 52
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ethics Committee
Study ID:
BO17705
NCT ID:
NCT00738530
Start Date:
June 2004
Completion Date:
August 2011
Related Keywords:
- Renal Cell Cancer
- Carcinoma, Renal Cell
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