5 results
The main objective is to compare the efficacy and safety of esophageal dilation with the balloon the Savary bougie dilator according to the rule-of-3 to rule-of > 3 strategy during 6 months in patients with a severe benign esophageal…
Primary objectives: Part I: Feasibility of 89Zr-GC1008 PET imaging in patients with suspicion of a malignant glioma to assess if GC1008 penetrates into the brain tumor and to quantify its uptake. Part II: 89Zr-GC1008 PET imaging in patients with…
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…
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…