3 results
Approved WMORecruiting
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…
Approved WMOCompleted
Phase IPrimary Objective- To define the recommended phase II dose (RP2D) of selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALLSecondary Objectives- To evaluate safety and…
Approved WMOCompleted
Primary objectives:- To determine the PK of selumetinib after administration of the selumetinib granule formulation. - To assess the safety and tolerability of the selumetinib granule formulation.