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

Chong Kun Dang Pharmaceutical1 site in 1 country24 target enrollmentDecember 2016

ConditionsColorectal Cancer

InterventionsCKD-516 Tablet

DrugsCKD-516 Tablet

Overview

Phase: Phase 1
Intervention: CKD-516 Tablet
Conditions: Colorectal Cancer
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 24
Locations: 1
Primary Endpoint: Maximum Tolerated Dose(MTD)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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)

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

June 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

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

Arms & Interventions

Treat Regimen

CKD-516(investigational Drug) Irinotecan

Intervention: CKD-516 Tablet

Outcomes

Primary Outcomes

Maximum Tolerated Dose(MTD)

Time Frame: Up to 14 days(for 1st cycle)

Secondary Outcomes

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)