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
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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
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
No
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
No
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
Email
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
Email
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
derived
Learn more about this trial
A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.
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