10 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: 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…
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 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…
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)…
Lu AF28996 is an orally administered investigational compound of a potent, long-acting dopamine agonist, Lu AA40326, currently under development by H. Lundbeck A/S for the treatment of Parkinson*s disease (PD). Primary Objective:to investigate the…
Primary: To evaluate the long-term safety of repeated subcutaneous(SC) administrations of lanadelumab in adolescents and adults with nonhistaminergicangioedema with normal C1-INH
Primary: To evaluate the efficacy of repeated subcutaneous (SC) administrations of lanadelumab in preventing angioedema attacks in adolescents (12 to <18 years of age) and adults with non-histaminergic angioedema with normal C1-INH.Secondary…
The objectives of this study:• To generate the proof of concept for lanadelumab for treatment of symptoms of COVID-19 disease • To demonstrate its safety after intravenous administration.