HIPPoS
Research type
Research Study
Full title
Proof of mechanism study of an oral hedgehog inhibitor (GDC-0449) in patients with resectable pancreatic ductal adenocarcinoma in the pre-operative window period.
IRAS ID
45006
Contact name
David Tuveson
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2010-018776-24
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This clinical trial is looking at the effect of a new drug called GDC-0449 in patients with cancer of the pancreas. Laboratory studies have shown that this drug blocks a process in pancreatic cells thought to be involved in cancer development and spread. This process is called the ‘Hedgehog signalling pathway’. As yet, it is unclear whether blocking hedgehog signalling will directly affect the tumour cells themselves or the surrounding normal tissue. Understanding this distinction will help improve treatment strategies for pancreatic cancer. Patients will be offered to participate in this research study if they have localised pancreatic cancer that can be removed by surgery. In the period between diagnosis and surgery we do not normally treat patients, however in this trial we will ask patients to take GDC-0449 during the approximately two weeks until the day of surgery. All patients that enter this study will have undergone a diagnostic biopsy of the pancreatic tumour and we will collect a second sample of the tumour at surgery. The main question of this study is whether we can detect a change in hedgehog signalling in the tumour tissue. Furthermore we will look very carefully whether this treatment is safe for patients. All problems before and after surgery will be carefully documented and we have defined strict rules to stop the study if we observe serious problems.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
10/H0304/76
Date of REC Opinion
21 Oct 2010
REC opinion
Further Information Favourable Opinion