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Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers

NCT01028859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-12-22

No results posted yet for this study

Summary

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).

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Yung-Jue Bang, MD., PhD. · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028859 on ClinicalTrials.gov