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

NCT03076957 | Unknown Phase 1

• 1 other identifier: 127CRC16009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose(MTD)

  Up to 14 days(for 1st cycle)

Secondary Outcomes (2)

• Pharmacokinetics(Cmax)

  1st Cycle Day1: up to 24hr

• 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

Study Arms (1)

Treat Regimen

EXPERIMENTAL

CKD-516(investigational Drug) Irinotecan

Drug: CKD-516 Tablet

Interventions

CKD-516 Tablet DRUG

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

Also known as: CKD-516

Treat Regimen

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 33829355 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

N-(4-(3-(1H-1,2,4-triazol-1-yl)-4-(3,4,5-trimethoxybenzoyl)phenyl)thiazol-2-yl)-2-amino-3-methylbutanamide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tae won KIM, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae won KIM, MD

CONTACT

twkimmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: March 10, 2017
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

KR (1)