A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma

Status Completed

Clinical Trial Summary

The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.

Clinical Trial Description

This research study uses a type of drug called anti-IL-6 monoclonal antibody, also known as CNTO 328. CNTO 328 is a new experimental drug. This study is trying to better understand the safety, the tolerability (side effects), and the distribution of the drug in the blood stream. The effects of CNTO 328 in patients with renal cell carcinoma are currently unknown. However, recent data has shown that treatment with another anti-IL-6 monoclonal antibody reduces the symptoms of renal cell carcinoma.

The study is divided in 3 parts. Part 1 is the phase I portion of the study and evaluated the safety of CNTO 328 in subjects with metastatic renal cell carcinoma. Part 2 and 3 will evaluate efficacy and safety of the drug in this patient population. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00265135
Study type	Interventional
Source	Centocor, Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2003
Completion date	February 2006

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