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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Ovarian NeoplasmsPancreatic NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsLung 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

Trial Locations (12)

Unknown

Philadelphia

Houston

Brussels

Wilrijk

Caen

Lyon

Villejuif

Barcelona

Madrid

Birmingham

Edinburgh

Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY