The primary objective of this Phase 1 study is to identify the recommended dose of capiri and of sunitinib for combination therapy subsequent phase II trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
A dose escalating study in a 3 + 3 design will be performed. At MTD dose 14 additional patients will be treated. First, the optimal dose of sunitinib in a continuous schedule will be determined, thereafter, further dose escalation of capecitabine and irinotecan will be investigated.
University Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, Netherlands
RECRUITINGMaximum Tolerated Dose
Time frame: after every completed doselevel
determine the safety and toxicity profile using the CTCAE criteria.
Time frame: after every completed doselevel
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