31 results
Reduction of polycystic liver volume by treating with octreotide, whether or not combined with everolimus. Assessing whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide…
Phase I- To characterize the safety and tolerability and determine the maximum tolerated dose of daily RAD001 in combination with daily sorafenibPhase II- To estimate the hazard ratio of the treatment effect as measure of anti-tumor activity of the…
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 compare overall survival between RAD001+BSC and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
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 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…
To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.
To determine whether treatment with everolimus 10 mg daily plus best supportive care prolongs PFS compared with placebo plus best supportive care in patients with advanced NET of GI or lung origin without a history of carcinoid symptoms
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…
The objective of this study is to determine whether influencing the protein pathway thought to underlie TSC by Everolimus treatment will improve cognitive abilities in these children.
Primary objectives:- To evaluate the effect of old age (* 70 years) on everolimus pharmacokinetics (AUC0-24hr)- To evaluate the effect of obesity (BMI * 30 kg/m2) on everolimus pharmacokinetics (AUC0-24hr)Secondary objectives:- To evaluate whether…
Primary: To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs. Key secondary: Ability to completely…
To determine whether treatment with RAD001 10 mg/d plus best supportive care prolongs the progression free survival (PFS) compared to treatment with Placebo plus best supportive care in patients with advanced pancreatic neuroendocrine tumor.
With the goal of improving kidney function and without causing an increased number of rejections, is it possible to reduce tacrolimus dosage through the use of the previously-mentioned immunosupressives after month three.
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 compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…
Objecive of phase I was the determination of the maximum tolerated dose (MTD) and recommended phase II dose of BI836845 in combination with exemestane and everolimus in women with HR+ / HER2- locally advanced or metastatic breast cancer.Ojective of…
Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…