2 results
Approved WMOCompleted
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…