134 results
The primary objective of the study is evaluating the safety, tolerance and anti-lymphoma activity of the anti-CD79b-MMAE conjugate (DCDS4501A) and the anti-CD22-MMAE conjugate (DCDT2980S), both given in combination with Rituximab once every 4 weeks…
Primary:* To evalaute the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC* To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III. Secondary:* To study safety and tolerability (…
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
The primary objective is:To evaluate the efficacy of pomalidomide (CC-4047) monotherapy in subjects with refractory orrelapsed and refractory multiple myeloma who discontinued treatment after being treated withdexamethasone alone (Treatment Arm B)…
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with DLBCL (dose expansion).
Compare efficacy and safety ofpomalidomide versus placebo in reversing RBC-transfusiondependence in subjects with MPN-associated myelofibrosis and RBC-transfusion-dependence. Investigate variables correlated with RBC-transfusion-independence and/or…
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.
The study the influence of two different inhalationflow manoeuvres on the lungdeposition in patients with cystic fibrosis categorized to patientgroups varying in FEV1 longfunction value and age.
Primary: To demonstrate the superior efficacy (composite of all-cause death + Myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatideSecondary:• To demonstrate the superior efficacy ( composite of all-cause death +…
Primary: To assess the effects of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy, evaluated at day 120.Secondary: To assess the safety…
Primary:To assess the effect of various degrees of impairment in hepatic function as measured by NCICTEPcriteria, on the pharmacokinetics of panobinostat.Secondary:To assess the effect of various degrees of hepatic functions on the safety of…
to confirm that GMC 252 is absorbed in humansto determine in humans whether GMC 252 is cleaved, yielding diflunisal and N-acetylcysteine (NAC)to determine whether additional metabolites are formed with GMC-252 compared with diflunisal and NAC
The objective of this study is to demonstrate (1) the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and women aged…
The purpose of the study is to investigate whether the cyclodextrin added to the cholecalciferol formulation has an effect on the vitamin D3 availability in the body. Thus, it will be investigated if concentrations of vitamin D3 that are found in…
To estimate the treatment effect as measured by progression free survival(PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumabrelative to paclitaxel + bevacizumab + placebo.
To assess sorafenib pharmacokinetics and biodistribution, K-Ras mutational status, tumor uptake and tumor response in NSCLC patients.