Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD, Maximum Tolerated Dose
Yung-Jue Bang, MD., PhD.
Seoul National University Hospital
South Korea: Korea Food and Drug Administration (KFDA)