Colorectal Cancer
Conditions
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)
Interventions
DRUGCKD-516 Tablet
CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.
Sponsors
Asan Medical Center
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged 19 years or older 2. Patients who failed existing anti-cancer therapies 3. ECOG performance status ≤ 1 4. Life expectancy of ≥ 12 weeks 5. Adequate hematological, hepatic and renal functions: 6. Patients who give written informed consent voluntarily
Exclusion criteria
1. 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) 2. 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) 3. 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.) 4. 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) 5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months 6. Uncontrolled arrhythmia 7. Significant cerebrovascular diseases including stroke within 6 months 8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases 9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease 10. 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 11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP 12. Pregnancy or breast-feeding 13. 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 14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation 15. Patients who cannot participate in this trial by investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose(MTD) | Up to 14 days(for 1st cycle) |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactTae won KIM, MD
Outcome results
None listed