A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 ADMINISTERED IN A CONTINUOUS DAILY REGIMEN IN PATIENTS WITH CYTOKINE-REFRACTORY METASTATIC RENAL CELL CARCINOMA

Update Il y a 5 ans
Reference: EUCTR2005-001270-27

Woman and Man

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Extract

- To evaluate the activity of SU011248 in cytokine-refractory metastatic RCC when administered in a continuous treatment regimen - To evaluate the safety and tolerability of SU011248 administered in a continuous treatment regimen - To evaluate the tolerability of SU011248 administered in the morning versus in the evening prior to sleep - To assess patient reported outcomes (PRO) - To determine SU011248 and SU012662 trough concentrations (Ctrough) for evaluation of steady-state pharmacokinetics -To explore the correlations of potential biomarkers with clinical outcomes


Inclusion criteria

  • Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology