Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028859
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Yung-Jue Bang, MD., PhD.||Seoul National University Hospital|