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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: CKD-516 Tablet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Tae won KIM, MD; Email: twkimmd@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Pharmacokinetics(Cmax)	1st Cycle Day1: up to 24hr

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Asan Medical Center
• Investigators: Principal Investigator: Tae won KIM, MD, Asan Medical Center

Publications and helpful links

General Publications

• Jeong H, Hong YS, Kim JE, Lim HS, Ahn JB, Shin SJ, Park YS, Kim ST, Han SW, Kim TY, Kim TW. A phase 1 dose-escalation and dose-expansion study to assess the safety and efficacy of CKD-516, a novel vascular disrupting agent, in combination with Irinotecan in patients with previously treated metastatic colorectal cancer. Invest New Drugs. 2021 Oct;39(5):1335-1347. doi: 10.1007/s10637-021-01110-9. Epub 2021 Apr 7.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 127CRC16009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED