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:1) Describe the PD effects on plasma ACTH and serum cortisol upon 100 µg hCRH injection with or without a preceding injection of 10 µg dDAVP 2 hours earlier and study the PK-PD relationship (*Block B*). In particular, the outcome…
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…
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.
The central aim of the POEM Study: to investigate whether the early start of metformin on top of standard care may improve the treatment of GDM for mother and child. Metformin is used as a tool to reduce insulin resistance, the underlying cause of…