11 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)…
The research question of the main study is: What are the short- and long-term effects and costs of helmet treatmentcompared to a wait-and-see regimen for a period of 6 months on skull asymmetry in children withmoderate to severe DP.The objective of…
To collect long term data on safety and tolerability of dovitinib monotherapy.
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…
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…
The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…
Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.