A phase II trial of RAD001 in neuro-endocrine tumours
Research type
Research Study
Full title
RAMSETE: A single arm, multicenter, single-stage phase II trial of RAD001 in Advanced and Metastatic Silent neuro-Endocrine Tumours in Europe
IRAS ID
19110
Sponsor organisation
Novartis Pharma AG
Eudract number
2008-006182-88
Clinicaltrials.gov Identifier
Research summary
This clinical research study is a Phase II study to investigate the effects of RAD001 (everolimus) as monotherapy in patients with metastatic neuro-endocrine tumours. RAD001 (everolimus) acts directly on the tumour cells, preventing cell growth and spread of the tumour to other areas of the body. The rationale for this study is that currently available therapies have little impact on control of tumour growth. There are preclinical and clinical data to support the use drugs such as RAD001 (everolimus) in neuro-endocrine tumours. The study design is open label, non-randomised, single arm and multicentre. This means that there is only one drug being used, RAD001 (everolimus), and all patients on the trial will receive this. They will all be told that they are receiving RAD001 (everolimus). The study will take place in 3 different sites across the UK recruiting a total of 12 patients. This represents part of a larger European study in France, Germany, Spain, Italy and Poland, where up to 60 patients will be recruited in total. Patients who are over 18 and have been diagnosed with metastatic neuro-endocrine tumours will be eligible. The study is expected to last until patients show signs of disease progression. They will then be followed for a further 2 years for monitoring of their disease and general health. The primary research objective is to evaluate the percentage of patients who show a complete or partial disease response. Patients will receive radiological sans to monitor for disease progression. Other procedures that will be used for this study are blood and urine tests and a complete physical examination.The study will also be evaluating the following secondary endpoints; disease control rate, biochemical response, duration of response, median progression free survival and overall survival.
REC name
West of Scotland REC 1
REC reference
09/S0703/70
Date of REC Opinion
7 Jul 2009
REC opinion
Further Information Favourable Opinion