Status:
UNKNOWN
NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors
Lead Sponsor:
National OncoVenture
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical
Conditions:
Advanced Refractory Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 NOV120401 (CKD-516 Tablet), a novel vas...
Detailed Description
Vascular disrupting agents are expected to kill cancer cells located in core of tumor tissues by disrupting microvascular structure of tumor. To assess the safety and tolerability of NOV120401 (CKD-51...
Eligibility Criteria
Inclusion
- Male or female patients aged 19 years or older
- Patients who failed existing anti-cancer therapies
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
- Adequate hematological, hepatic and renal functions:
- Patients who give written informed consent voluntarily
Exclusion
- 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 2 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02300467
Start Date
December 1 2014
End Date
July 1 2016
Last Update
August 14 2015
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769