2 results
Approved WMOCompleted
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
Approved WMOCompleted
Primary, to show that a single intravesical instillation of chemotherapy immediately before radical surgery for an upper urinary tract (UUT) urothelial carcinoma leads to a 40% reduction in the risk of a subsequent bladder recurrence (urothelial…