The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of CKD-516 Tablet in Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal Cancer
CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.
Asan Medical Center
Seoul, South Korea
RECRUITINGMaximum Tolerated Dose(MTD)
Time frame: Up to 14 days(for 1st cycle)
Pharmacokinetics(Cmax)
Time frame: 1st Cycle Day1: up to 24hr
Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
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