A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas
Using the phase I study design, the dose of gemcitabine will be escalated in several steps
to identify the highest tolerable dose that can be given safely. Based on pre-defined
dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and
a safer dose for further evaluation of this regimen in pancreatic cancer selected. The
primary objectives are therefore based around safety of the drug combination.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome measure for the study is to establish the Maximum Tolerated Dose of the drug regimen based on the endpoint of dose-limiting toxicity
1 year
Yes
David Cunningham
Principal Investigator
Royal Marsden NHS Foundation Trust
United Kingdom: Research Ethics Committee
CCR2731
NCT01048320
July 2006
December 2010
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