6 results
The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
The primary objective is to determine the effect of high-dose sunitinib versus standard treatment with lomustine on six-month progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria. Secondary objectives are:1. To…