A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors

Summary

The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.

Conditions

• Ovarian Neoplasms
• Pancreatic Neoplasms
• Colorectal Neoplasms
• Head and Neck Neoplasms
• Lung Neoplasms

Interventions

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 2.8 milligram per kilogram (mg/kg) will be administered as 1-hour intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1, Day 28, Day 42 and Day 56

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 5.5 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 42 and Day 56

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 11 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 49 and Day 70

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 49 and Day 70

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days to participants with ovarian cancer.

DRUG

CNTO 328; Anti-interleukin-6 monoclonal antibody

Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days to participants with tumors harboring Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations or pancreatic cancer, or non-small cell lung cancer (NSCLC), colorectal cancer (CRC), or head and neck (H\&N) cancer that were refractory or resistant to anti-epidermal growth factor receptor (EGFR) therapy

Sponsors & Collaborators

• Centocor, Inc.

  lead INDUSTRY

Principal Investigators

• Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• United States
• Belgium
• France
• Spain
• United Kingdom

Study Locations