Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
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|ClinicalTrials.gov Identifier: NCT01028859|
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: CKD-516 inj||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|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
- MTD, Maximum Tolerated Dose [ Time Frame: 1st cycle ]
- 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 ]
- Dose-limiting Toxicity [ Time Frame: 1st cycle ]
- ORR%, Objective response rate [ Time Frame: every 2 cycle ]
- PFS, Progression Free Survival [ Time Frame: 30 days before or after last patient out ]
- Vascular disruption effect(with DCE-MRI) [ Time Frame: 24hr after 1st cycle day 1 treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|