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

This study has been completed.
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
First received: December 13, 2005
Last updated: November 24, 2010
Last verified: November 2010

December 13, 2005
November 24, 2010
July 2003
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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.
Same as current
Complete list of historical versions of study NCT00265135 on ClinicalTrials.gov Archive Site
Secondary outcomes that will be looked at are: PD markers; disease progression; clinical benefit; Quality of Life; Survival
Same as current
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A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (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.

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.

Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: CNTO 328
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2006
Not Provided

Inclusion Criteria:

  • Age = 18 years old
  • diagnosis of metastatic renal cell carcinoma
  • documented disease progression

Exclusion Criteria:

  • Received any investigational drug within past 30 days
  • Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure
  • chronic infection, prior history of recurrent infection, or clinically important active infection
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP