7 results
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…
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 is to assess the effect a resuscitation strategy using balanced solutions versus unbalanced solutions on regional and microvascular perfusion relative to global hemodynamics in intensive care patients following elective cardiac…
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…
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…
Main objective: Proportion of subjects who remain treatment-free.Secondary objectives: - Change from Baseline in Patient Reported Outcomes (PROs) (PROMISPF, EQ-5D-5L)- Safety: Total number of subjects in the safety analysis set with any AEcollected…
Primary ObjectivesTo assess the effects of pexidartinib on the PK parameters of single-dose midazolam and tolbutamide in patients.Secondary ObjectivesTo evaluate:- To determine the overall response rate (ORR) in patients with TGCT,kit-mutant…