A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)

Official Title
-----------------
A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj. in Patients With Previously Treated Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: CKD-516 Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged 19 years or older Patients who failed existing anti-cancer therapies ECOG performance status ≤ 1 Life expectancy of ≥ 12 weeks Adequate hematological, hepatic and renal functions: Patients who give written informed consent voluntarily Exclusion Criteria: Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation) Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation) Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.) NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP > 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF < 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages) Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months Uncontrolled arrhythmia Significant cerebrovascular diseases including stroke within 6 months Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP Pregnancy or breast-feeding Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 3 months after the end of treatment Patients who received other investigational products or used other investigational devices within 3 weeks before participation Patients who cannot participate in this trial by investigator's discretion

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treat Regimen<br>CKD-516(investigational Drug) Irinotecan | Drug: CKD-516 Tablet<br>* CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.<br>* Other names: CKD-516;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose(MTD) |  | Up to 14 days(for 1st cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics(Cmax) |  | 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 |  | through study completion, an average of 1 year |