AFINITOR SUMMARY
AFINITOR (everolimus), an inhibitor of mTOR, is an antineoplastic agent.
AFINITOR® is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
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NEWS HIGHLIGHTS
Published Studies Related to Afinitor (Everolimus)
Everolimus for subependymal giant cell astrocytoma in patients with tuberous
sclerosis complex: 2-year open-label extension of the randomised EXIST-1 study. [2014]
continuing 4-year extension phase of EXIST-1... INTERPRETATION: These results support the longer-term use of everolimus in
A randomized phase II study of everolimus for advanced pancreatic neuroendocrine
tumors in Chinese patients. [2014]
Everolimus, an oral inhibitor of mammalian target of mTOR, has been recently
shown to have antitumor effect in a phase III, double-blind, randomized trial
(RADIANT-3) of 410 patients with advanced pancreatic neuroendocrine tumors
(PNETs). The purpose of this study was to investigate the specific efficacy and
safety of everolimus in the Chinese patient with PNETs...
Efficacy and safety of everolimus for subependymal giant cell astrocytomas
associated with tuberous sclerosis complex (EXIST-1): a multicentre, randomised,
placebo-controlled phase 3 trial. [2013]
subependymal giant cell astrocytomas associated with tuberous sclerosis complex... INTERPRETATION: These results support the use of everolimus for subependymal
Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer:
BOLERO-2 final progression-free survival analysis. [2013]
this patient population... CONCLUSION: The addition of everolimus to exemestane markedly prolonged PFS in
Everolimus for previously treated advanced gastric cancer: results of the
randomized, double-blind, phase III GRANITE-1 study. [2013]
gastric cancer... CONCLUSION: Compared with BSC, everolimus did not significantly improve overall
Clinical Trials Related to Afinitor (Everolimus)
Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination vorinostat given in combination with either sirolimus, everolimus or
temsirolimus that can be given to patients with advanced cancer. The safety of this drug
combination will also be studied.
Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) [Completed]
Tuberous Sclerosis Complex (TSC) is a multi-system disease, usually presenting with
seizures, mental retardation and autism, and exhibiting a high variability in clinical
findings both among and within families. Investigators are doing research in order to
identify possible neurocognitive benefits from treatment with RAD001 or placebo for a six
month period. There may also be potential for improvements in seizure frequency, sleep and
autistic behaviors. We hope this trial will lead to a better understanding of TSC and to
new forms of treatment, to benefit children and adults with TSC in the future.
Individuals diagnosed with TSC will be asked to participate in this study if they are
between the ages of 6 and 21 years of age and have an IQ of greater than or equal to 60.
Both males and females will be asked to participate. Additionally, to be eligible for study
participation, individuals must have been on the same seizure medication(s), if applicable,
for at least 6 months. Individuals must also be able to participate in neuropsychological
testing and meet certain medical criteria. They will need to sign an informed consent. If
enrolled in the study, participants will have a number of screening tests to help determine
if they are eligible for participation in the clinical trial. If eligible for the treatment
phase of the trial, they will be asked to take either the study drug or a placebo (pill with
no medicine), which is determined by chance.
The study involves about 9 visits, 3 of which can be done locally, over a six month period,
as well as follow-up calls with our research nurse. Study visits will vary in length.
Screening, three month and six month visits may last up to 8 hours, while all other visits
will be less than 2 hours. The study visits include blood draws, laboratory tests and
neuropsychological assessments. There is no fee to participate in this study. Some
compensation may be available for travel costs of out-of-state participants based on fund
availability. The study drug will be provided at no charge during the study.
After all study data has been analyzed, families will be informed of the overall results.
Treatment on this study may or may not improve a child's learning skills (neurocognition).
Future patients may benefit from what is learned.
Dose Finding Study of RAD001 (Everolimus, Afinitor�) in Combination With BEZ235 in Patients With Advanced Solid Tumors [Completed]
Study has two parts:
1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety
and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in
patients with advanced solid tumors.
2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in
patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer
Phase I/Ib Dose Escalation & Biomarker Study of Ceritinib (LDK378) + Everolimus for Locally Advanced or Metastatic Solid Tumors With an Expansion in Non-Small Cell Lung Cancer (NSCLC) Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expression [Not yet recruiting]
The goal of this clinical research study is to find the highest tolerable dose of ceritinib
(LDK378) and everolimus that can be given to patients with NSCLC or head and neck cancer.
The safety of the drug combination will also be tested.
Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer [Recruiting]
This study consists of two parts. In a phase Ib part, investigators will explore the
recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with
metastatic TNBC. After completing the phase Ib part, investigators will review the data and
discuss with Novartis before the start of a phase II part. In the phase II part,
investigators will compare the efficacy of the gemcitabine and cisplatin with or without
RAD001 in patients with metastatic TNBC.
Reports of Suspected Afinitor (Everolimus) Side Effects
Neoplasm Malignant (362),
Neoplasm Progression (337),
Death (296),
Fatigue (196),
Dyspnoea (190),
Pyrexia (173),
Diarrhoea (150),
Cough (123),
Pneumonia (119),
Anaemia (113), more >>
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Page last updated: 2015-08-10
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