12 results
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
The purpose of this phase Ib study is to determine the maximum tolerated dose (MTD) of i.v. and oral panobinostat when given in combination with trastuzumab and paclitaxel. Additional patients will be enrolled at the MTD to further evaluate the…
The primary objective is the Objective tumor response rate (RECIST). Secondary objectives are: duration of overall response, time to tumor progression (TTP), progression free survival (PFS), overall survival, toxicity profile, incidence of…
The Primary Objective of the study is to dettermine the relative efficacy of AZD2171 [RECENTIN] (both monotherapy or in combination with oral lomustine) compared to oral lomustine alone by assessment of progression free survival (PFS) as assessed by…
Investigate the activity and safety of amrubicin alone versus amrubicin incombination with cisplatin versus standard treatment for extensive disease(ED) small-cell lung cancer in the first line setting.
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
To decrease the cumulative incidence of (hematological) relapse
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…