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 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).
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 in Patients With Advanced Solid Cancers Failed to Standard Therapy|
- MTD, Maximum Tolerated Dose [ Time Frame: 1st cycle ] [ Designated as safety issue: Yes ]
- PK parameters of CKD-516 and its metabolite, S516, when CKD-516 administered on Days 1 and 8 of a 21-day cycle [ Time Frame: 1st cycle ] [ Designated as safety issue: No ]
- Dose-limiting Toxicity [ Time Frame: 1st cycle ] [ Designated as safety issue: Yes ]
- ORR%, Objective response rate [ Time Frame: every 2 cycle ] [ Designated as safety issue: Yes ]
- PFS, Progression Free Survival [ Time Frame: 30 days before or after last patient out ] [ Designated as safety issue: Yes ]
- Vascular disruption effect(with DCE-MRI) [ Time Frame: 24hr after 1st cycle day 1 treatment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Experimental: CKD-516 inj||
Drug: CKD-516 inj
5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks
Other Name: CKD-516
- I. Determine the maximum tolerated dose of CKD-516 administered at single doses every 21 days in patients with advanced solid tumors.
- II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
- III. Determine the plasma and urine pharmacokinetics of CKD-516.
- IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI scanning techniques, and establish the dose at which these effects occur.
OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 8 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.
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Yung-Jue Bang, MD., PhD.||Seoul National University Hospital|