Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-06 @ 1:26 PM
Study NCT ID:
NCT03076957
Status:
UNKNOWN
Last Update Posted:
2017-03-10
First Post:
2016-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552333', 'term': 'N-(4-(3-(1H-1,2,4-triazol-1-yl)-4-(3,4,5-trimethoxybenzoyl)phenyl)thiazol-2-yl)-2-amino-3-methylbutanamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose(MTD)', 'timeFrame': 'Up to 14 days(for 1st cycle)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics(Cmax)', 'timeFrame': '1st Cycle Day1: up to 24hr'}, {'measure': 'Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '33829355', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients aged 19 years or older\n2. Patients who failed existing anti-cancer therapies\n3. ECOG performance status ≤ 1\n4. Life expectancy of ≥ 12 weeks\n5. Adequate hematological, hepatic and renal functions:\n6. Patients who give written informed consent voluntarily\n\nExclusion Criteria:\n\n1. 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)\n2. 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)\n3. 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.)\n4. 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)\n5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months\n6. Uncontrolled arrhythmia\n7. Significant cerebrovascular diseases including stroke within 6 months\n8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases\n9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease\n10. 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\n11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP\n12. Pregnancy or breast-feeding\n13. 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\n14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation\n15. Patients who cannot participate in this trial by investigator's discretion"}, 'identificationModule': {'nctId': 'NCT03076957', 'briefTitle': 'A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '127CRC16009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treat Regimen', 'description': 'CKD-516(investigational Drug) Irinotecan', 'interventionNames': ['Drug: CKD-516 Tablet']}], 'interventions': [{'name': 'CKD-516 Tablet', 'type': 'DRUG', 'otherNames': ['CKD-516'], 'description': 'CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.', 'armGroupLabels': ['Treat Regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae won KIM, MD', 'role': 'CONTACT', 'email': 'twkimmd@amc.seoul.kr'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Tae won KIM, MD', 'role': 'CONTACT', 'email': 'twkimmd@amc.seoul.kr'}], 'overallOfficials': [{'name': 'Tae won KIM, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}