12 results
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…
This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1…
The study will be performed in 2 cohorts, Cohort 1 and Cohort 2. In Cohort 1, it will be investigated what the effect is of itraconazole on how quickly and to what extent APX001 is absorbed and excreted by the body (this is called pharmacokinetics…
5.1 Study hypothesisThe primary study hypothesis states that oral treatment with itraconazole will reduce the epistaxis severity score (ESS) due to the anti-angiogenic effects of itraconazole.5.2 Research question and primary outcomeWhat is the…
Main objective: - Evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein (P-gp) inhibitor, on the safety and tolerability (including "thorough" electrocardiogram [ECG] assessment) and…
- To assess the effect of food (high-fat) on the bioavailability and pharmacokinetic (PK)- profile of a solid dosage formulation of JNJ-67953964.- To assess the effects of repeated QD administration of 200 mg of itraconazole (steady state) on the…
- The primary objective of the Stratum 1A cohort is to establish the maximum tolerated dose of single agent InO when administered in children with CD22-positive relapsed/refractory BCPALL.- The primary objective of the phase 2 cohort is to establish…
The purpose of this study is to investigate the effect of multiple doses of itraconazole on how quickly and to what extent the new compound PHA-022121 is absorbed into the body and eliminated from the body (this is called pharmacokinetics). It will…
In this study we will look at how quickly and to what extent the study compound MEN1611 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics) and how this is influenced by the approved drug itraconazole fluvoxamine…
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…
Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1 and < 18 years with HR first bone marrow relapse CD22-positive BCP ALL Secondary Objectives:Key Secondary…
The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute lymphoblastic leukaemia