5 results
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
Primary objectives:- To evaluate whether the outcome in children, young people and adults with HR-MB is improved over standard therapy i.e. conventional (once a day) radiotherapy (RT) (standard therapy), for those treated with: hyperfractionated-…
PNET 5 MB-LR: Primary objective:-to confirm that the 3-year Event-Free Survival (EFS) rate in children and adolescents with standard-risk medulloblastoma having a low-risk biological profile remains in excess of 80% when patients are treated with 18…