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

NCT ID: NCT03076957

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-06-30

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)

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treat Regimen

CKD-516(investigational Drug) Irinotecan

Group Type: EXPERIMENTAL

CKD-516 Tablet

Intervention Type: DRUG

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

Interventions

CKD-516 Tablet

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

Intervention Type: DRUG

Other Intervention Names

CKD-516

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tae won KIM, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Tae won KIM, MD

Role: CONTACT

twkimmd@amc.seoul.kr

Facility Contacts

Tae won KIM, MD

Role: primary

twkimmd@amc.seoul.kr

References

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.

Reference Type: DERIVED

PMID: 33829355 (View on PubMed)

Other Identifiers

127CRC16009

Identifier Type: -

Identifier Source: org_study_id