drugset / Trial / NCT01028859

Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers

NCT01028859

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

EvaluationDrugModalityDoseRoute
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