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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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ClinicalTrials.gov Identifier: NCT03076957
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: CKD-516 Tablet Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: CKD-516




Primary Outcome Measures :
  1. Maximum Tolerated Dose(MTD) [ Time Frame: Up to 14 days(for 1st cycle) ]

Secondary Outcome Measures :
  1. Pharmacokinetics(Cmax) [ Time Frame: 1st Cycle Day1: up to 24hr ]
  2. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076957


Contacts
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Contact: Tae won KIM, MD twkimmd@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Tae won KIM, MD       twkimmd@amc.seoul.kr   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Asan Medical Center
Investigators
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Principal Investigator: Tae won KIM, MD Asan Medical Center

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03076957     History of Changes
Other Study ID Numbers: 127CRC16009
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents