All Drugs and Chemicals

Tubulin Modulators

5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 \~ mg/m2; Day 1, Day 8 every 3 weeks

CKD-516 inj

Yung-Jue Bang, MD., PhD.

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).

OBJECTIVES:

* 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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers	NCT01028859	Unspecified Adu...	CKD-516 inj	20 Years - 75 Years	Chong Kun Dang Pharmaceutical
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers	NCT01028859	Unspecified Adu...	CKD-516 inj	20 Years - 75 Years	Chong Kun Dang Pharmaceutical

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