drugset / Trial / NCT01560325
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
NaSingle-groupOpen-labelTreatment
Summary
A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.
Timeline
- Start
- 2012-06
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CKD-516 | Other / unclassified | 3.3 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 13 mg/m2 | Intravenous |