A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma|
- The primary objectives of Part 1 of the study are to assess the toxicity, pharmacokinetics, and pharmacodynamics of CNTO 328 in subjects with metastatic renal cell carcinoma, so that 2 possible dose levels can be evaluated in Part 2.
- Secondary outcomes that will be looked at are: PD markers; disease progression; clinical benefit; Quality of Life; Survival
|Study Start Date:||July 2003|
|Study Completion Date:||February 2006|
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.