47 results
PrimaryTo estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a…
The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.
The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease.- To evaluate the safety of IV induction regimens of…
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 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.
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.
To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
Primary objective:Analyze the value of pneumoproteins, everolimus exposure, pulmonary function tests, distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the prediction of the…
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 allow continued use of everolimus to patients receiving everolimus in a Novartis-sponsoredstudy which has reached its objectives and who are benefitting from treatment with everolimus as defined in the parent protocolSecondary: To…
Primary objectivesThe primary objective is to assess the progression-free survival (PFS) of patients who receive bi-monthly rotations of Pazopanib and Everolimus versus patients who receive Pazopanib as a first line treatment. Secondary…
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
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…
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…
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.…
Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…
The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…
Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…
To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.