Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS)
Status:
Terminated
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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
the investigators do not normally treat patients, however in this trial the investigators
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 the investigators will collect a second sample of the tumour at
surgery. The main question of this study is whether the investigators can detect a change in
hedgehog signalling in the normal tumour surrounding tissue. Furthermore the investigators
will look very carefully whether this treatment is safe for patients. All problems before and
after surgery will be carefully documented and the investigators have defined strict rules to
stop the study if the investigators observe serious problems.