NCT03076957

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CKD-516 Tablet	CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2017-03-10
• Last updated: 2017-03-10

Locations

1 site across 1 country: South Korea