Clinical trial · Interventional
NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors
A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of NOV120401 (CKD-516 Tablet) in Patients With Advanced Refractory Solid Tumors
NCT02300467CI-TRIAL-00018841unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 vascular disrupting agent, in patients with advanced refractory solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Refractory Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NOV120401 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NOV120401 (CKD-516 Tablet)
- description
- 5 to 45 mg/day PO for 5 consecutive days and 2 days off
- interventionNames
- Drug: NOV120401
Primary outcomes (1)
- measure
- Safety and MTD/recommended phase 2 dose (RP2D) determination (Number of Participants with Adverse Events)
- timeFrame
- By 40 weeks after enrollment of the last subject
- description
- Number of Participants with Adverse Events
Secondary outcomes (4)
- measure
- Pharmacokinetic profiles (Cmax, Tmax, AUClast, AUCinf, t1/2, CL, MRT, Ctrough) of CKD-516 and S516 (active metabolite of CKD-516)
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients aged 19 years or older 2. Patients who failed existing anti-cancer therapies 3. ECOG performance status ≤ 2 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 2 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
References
Publications (0)
Data not yet available
No reference posted for this study.