A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.
Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events
The following abbreviations were used in the Adverse Events section:
- Gastrointestinal (GI)
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Gammaglutamyltransferase (GGT)
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor Response of a subject was defined as the best tumor response observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of tumor lesion sizes, Stable Disease (SD) was defined as steady state of disease, or Progressive Disease (PD) was defined as an increase in the sum of tumor lesions sizes.
From start of treatment assessed every 2 cycles up to 6 cycles
Bayer Study Director
France: Direction Générale de la Santé