Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: CKD-516 inj.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 Inj. Administered on A Twice-Weekly Schedule in Patients With Advanced Solid Cancers Failed to Standard Therapy|
- MTD, Maximum Tolerated Dose [ Time Frame: up to 21days (1st cycle) ] [ Designated as safety issue: No ]
- PK parameter of CKD-516 [ Time Frame: 0(Pre-dose), 24hrs post dose (1st cycle:Day 1), 0, 0.5, 4, 8, 24hours post-dose(1st cylcle: Day 11) ] [ Designated as safety issue: No ]
- DLT, Dose-limiting Toxicity [ Time Frame: up to 21days(1st cycle) ] [ Designated as safety issue: Yes ]
- ORR%, Objective response rate [ Time Frame: Up to 14 cycles (every 2 cycles) ] [ Designated as safety issue: Yes ]
- Vascular disruption effect [ Time Frame: 4hr, 24hr post-dose(1st cycle: Day 1) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: CKD-516 inj.
CKD-516 Inj, 3.3~13mg/m2/day, D1, 4, 8, 11 every 3 weeks
Drug: CKD-516 inj.
Other Name: CKD-516
This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 4, 8, 11 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560325
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Yung-Jue Bang||Seoul National University Hospital|