Trial Information

A Randomized Open Label Multicenter Phase II Study of First Line Therapy With Sorafenib in Association With IL-2 vs Sorafenib Alone in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

Patients will be allocated in 2 groups:

ARM A - Sorafenib 400 mg twice daily continuously and low dose of IL-2 administered s.c.

ARM B - Sorafenib alone at the same dosage used in the previous arm

The trial is stratified according to the MSKCC prognostic model (low intermediate high risk)
and histology (Clear cell vs other histotypes). The main inclusion criteria are:
cytohistological diagnosis of RCC, measurable disease as RECIST criteria, signed written
informed consent, life expectancy of greater than 3 months.

The efficacy and safety analysis will be performed on an intent to treat population.

The anticipated median PFS time in the control arm is 6 months and we will expect an
increase of 3 months in the experimental arm.

The sample size is 128 patients, 64 in each arm (1:1 randomization)

The study started in November 2006 and is a multicenter Italian trial.