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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076957
• Other study ID #: 127CRC16009
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 22, 2016
• Last updated: March 6, 2017
• Start date: December 2016
• Est. completion date: June 2019

Study information

• Verified date: March 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: Tae won KIM, MD
• Email: twkimmd[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• CKD-516 Tablet
CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose(MTD)		Up to 14 days(for 1st cycle)
Secondary	Pharmacokinetics(Cmax)		1st Cycle Day1: up to 24hr
Secondary	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