drugset / Trial / NCT01560325

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

NCT01560325

Phase 1 Completed 21 enrolled Chong Kun Dang Pharmaceutical
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

EvaluationDrugModalityDoseRoute
Subject CKD-516 Other / unclassified 3.3 mg/m2 Intravenous
Subject CKD-516 Other / unclassified 13 mg/m2 Intravenous