8 results
PrimaryTo assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are* with t(4;14)…
Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…
Primary objectives* To determine the Overall Response Rate (ORR) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258* To determine the Overall Response Rate (ORR) in patients with (FGFR3WT) advanced urothelial carcinoma…
With an one-off infusion of anti-thymocyte globulin (ATG) during the operation the T-cell function is decreased. With this action we try to achieve that DGF does not occur or that the length of the DGF is as short as possible and less frequent…
To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
To collect long term data on safety and tolerability of dovitinib monotherapy.
Primary Efficacy Objectives:The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of exposure to bexagliflozin in type 2 diabetic subjects with increased risk of cardiovascular…