drugset / Trial / NCT01028859
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
Phase 1
Completed
30 enrolled
Chong Kun Dang Pharmaceutical
Seoul National University Hospital · collab
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 a 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).
Timeline
- Start
- 2009-12
- Primary completion
- 2011-04
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CKD-516 | Other / unclassified | 1 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 2 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 3.3 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 5 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 7 mg/m2 | Intravenous |
| Subject | CKD-516 | Other / unclassified | 9 mg/m2 | Intravenous |