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

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-516 Tablet

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
Pregnancy or breast-feeding
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
Patients who received other investigational products or used other investigational devices within 3 weeks before participation
Patients who cannot participate in this trial by investigator's discretion

Sites / Locations

Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treat Regimen

Arm Description

CKD-516(investigational Drug) Irinotecan

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose(MTD)

Secondary Outcome Measures

Pharmacokinetics(Cmax)

Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

Full Information

NCT ID

NCT03076957

First Posted

December 22, 2016

Last Updated

March 6, 2017

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03076957

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Asan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treat Regimen

Arm Type

Experimental

Arm Description

CKD-516(investigational Drug) Irinotecan

Intervention Type

Drug

Intervention Name(s)

CKD-516 Tablet

Other Intervention Name(s)

CKD-516

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose(MTD)

Time Frame

Up to 14 days(for 1st cycle)

Secondary Outcome Measure Information:

Title

Pharmacokinetics(Cmax)

Time Frame

1st Cycle Day1: up to 24hr

Title

Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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 A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP Pregnancy or breast-feeding 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 Patients who received other investigational products or used other investigational devices within 3 weeks before participation Patients who cannot participate in this trial by investigator's discretion

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tae won KIM, MD

twkimmd@amc.seoul.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae won KIM, MD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tae won KIM, MD

twkimmd@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33829355

Citation

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.

Results Reference

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

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