A dose finding study in locally advanced and/or metastatic pancreatic cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Novartis Investigative Site
Halle, Germany
Novartis Investigative Site
Merseburg, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Oberstaufen, Germany
Novartis Investigative Site
Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine
Time frame: 8 weeks
Safety & tolerability, pharmacokinetic assessments of Everolimus and Gemcitabine combination therapy in these patient populations. Phase II objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS)
Time frame: 36 weeks
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Ulm, Germany