8 results
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 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…
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: 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.
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)…
The main study endpoint will be the mean preoperative morphine use per hour in patients with and without FICB with levobupivacaine, guided by ultrasound. Secondary parameters will include the pain scores reported by the numerical rating scale both…
Our overall aim is to measure several distinct MR parameters at 0.047 Tesla, and to use these to derive optimal MRI-protocols in terms of contrast and SNR. The images produced will then be compared with those from the commercial Hyperfine system.…