27 results
To determine the dose limiting toxicity (DLT) and the maximum tolerated dose and recommended dose of the combination of everolimus orally once daily and metformin orally BID to patients with advanced solid tumors.
Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…
The primary objective of the study is to evaluate additional safety of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinaseinhibitor therapy.
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
To evaluate the efficacy of the dose level/regimen(s) of RAD001recommended from the phase I with HT therapy. This will bebased on the evaluation of overall response rate according toRECIST [Post-Text Supplement 1].
Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…
To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.
The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…
(Protocol Am2 dd. 20-Feb-2014, p17/93)The primary objectives of this study are:- To evaluate the safety of sofosbuvir (SOF) 200 mg or 400 mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm-…
To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).
The aim of this study is to investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. Apart from renal…
Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2…
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…
Primary Objectives:• To assess the effects of VOR 200 mg BID on the steady-state PK of ATV administered as ATV/RTV300/100 mg QD in healthy subjects• To assess the effects of ATV/RTV 300/100 mg QD on the steady-state PK of VOR 200 mg BID inhealthy…
To determine the efficacy of the combination of everolimus and capecitabine in a group of patients with metastatic or locally advanced HCC with Child-Pugh class B liver cirrhosis. In addition, to investigate biomarkers of HCC before and during the…
The primary objective of the study is to determine the effect of atazanavir-induced hyperbilirubinemia on systemic activation of the innate immune response induced by human endotoxemia.Secondary objectives are:- To determine if the vascular…
In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with metatastatic pancreatic cancer
The study is designed to show that Certican® initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to…
To compare progression-free survival (PFS) in patients who receive RAD0901 plus Best Supportive Care (BSC) versus patients who receive Matching Placebo plus BSC.