5 results
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…
In order to set up paradigms for pharmaco-MRI studies for development of novel psychotropic medications. The present study will investigate the effect of: - low-dose benzodiazepine on brain activation and test performance on a testbed of well…
Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…