NEWS HIGHLIGHTS
Published Studies Related to Afinitor (Everolimus)
SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. [2009.10]
BACKGROUND: In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points)...
Role of everolimus in the treatment of renal cell carcinoma. [2009.10]
The therapeutic options in metastatic renal cell carcinoma have been recently expanded by the discovery of the VHL gene, the mutation of which is associated with development of clear cell carcinoma, and overexpression of the angiogenesis pathway, resulting in a very vascular tumor... Everolimus thus established itself as a standard of care in the second-line setting for patients with MRCC who have failed treatment with VEGF receptor inhibitors.
Contrast enhanced sonography shows superior microvascular renal allograft perfusion in patients switched from cyclosporine A to everolimus. [2009.07.27]
BACKGROUND: Real-time contrast enhanced sonography (CES) provides quantitative information on microvascular tissue perfusion in renal allografts. In contrast to calcineurin inhibitors, mammalian target of rapamycin inhibitors may have beneficial effects on renal microvascular tissue perfusion. There is no information on the microperfusion of renal allografts in patients receiving either mammalian target of rapamycin inhibitor or calcineurin inhibitor... CONCLUSION: The study demonstrates that renal microperfusion visualized by CES based on microbubble contrast agent and concomitantly kidney function, improved significantly after the switch from CsA to EVR.
Everolimus with reduced cyclosporine versus MMF with standard cyclosporine in de novo heart transplant recipients. [2009.07.15]
BACKGROUND: Pharmacokinetic modeling supports trough monitoring of everolimus, but prospective data comparing this approach versus mycophenolate mofetil (MMF) in de novo cardiac transplant recipients are currently unavailable... CONCLUSION: Concentration-controlled everolimus with reduced CsA results in similar renal function and equivalent efficacy compared with MMF with standard CsA at 12 months after cardiac transplantation.
Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus. [2009.07.15]
BACKGROUND: Concerns about delayed graft function (DGF) and wound healing complications with sirolimus has led to suggestions that everolimus introduction could be delayed after transplantation... CONCLUSIONS: Findings from this randomized, multicenter trial indicate that kidney function recovery, wound healing, efficacy, and tolerance are similar at 3 months posttransplant with immediate or DE in patients at protocol-specified risk of DGF.
Clinical Trials Related to Afinitor (Everolimus)
Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium [Recruiting]
The purpose of this study is to learn what effects, good and/or bad, Everolimus has on
advanced urothelial cancer.
The goal of this clinical research study is to learn if the study drug Everolimus can shrink
or slow the growth of urothelial cancer. The safety of this drug will also be studied. The
patients physical state, changes in the size of the tumor, and laboratory findings taken
while on-study will help us decide if Everolimus is safe and effective.
RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) [Recruiting]
The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different
dose levels, when added to docetaxel and cisplatin. We want to find out what effects, good
and/or bad, that everolimus has when added to docetaxel and cisplatin as treatment for head
and neck cancer.
Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia [Not yet recruiting]
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the
highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug
that works by preventing cells in the body from growing and dividing. Information from basic
and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor
growth in people with relapsed or refractory lymphoma.
Post-Operative Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer [Recruiting]
The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and
cisplatin to give to patients who are receiving radiation therapy after surgery for head and
neck cancer.
Randomized Phase I/II of RAD001 in Advanced Hepatocellular Carcinoma (HCC) [Recruiting]
The mTOR has been examined in hepatocellular carcinomas as well. This pathway is
up-regulated in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits
cell proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to
suppress substantially the liver tumor growth. Nevertheless, inhibition of mTOR was
demonstrated to have a clinical response in some cancer types. These reports imply that
inhibition of mTOR could be a promising therapeutic strategy in the treatment of HCC.
Therefore, we hypothesize that RAD001, a rapamycin analog, can inhibit the mTOR, and
subsequently suppress the liver tumor in the treatment of HCC patients.
This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics
and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I
study with dose escalation and subsequently a phase II study of intent to treat, as well as
pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.
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