6 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
The primary aim of this pilot-study is to assess safety and the effects on immune function in patients with septic shock of adjunctive therapy with IFN-gamma, in a placebo-controlled manner. The data obtained will allow us to do a powercalculation…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
Establishment of treatment area dose at which 90% technical success is achieved. Technical success will be defined as * 120Gy calculated radiation absorbed dose to the target area, i.e. the hyperaemic zone surrounding the area of post-RFA…