3 results
The primary objective of this study is to determine the maximum tolerated dose (MTD) for the administration of S80880.Secondary objectivesTo evaluate the safety profile of S80880.To describe the pharmacokinetics (PK) profile of S80880 administered…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…