29
Participants
Start Date
September 30, 2006
Primary Completion Date
May 31, 2009
Study Completion Date
May 31, 2009
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 0.1 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.1 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 0.3 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.3 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 1.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 1.0 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 3.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 3.0 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 10.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 10.0 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ ) Monoclonal Antibody
1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
1 dose of 15.0 or 10.0 mg/kg IV (based on safety profile of part 2, cohort 1) followed by a 28 day observation period and then 3 additional doses of 15.0 or 10.0 mg/kg IV (one dose every 14 days)
National Cancer Institute (NCI), Bethesda
Ohio State University, Columbus
Dana Farber/Harvard Cancer Center, Dana Farber Cancer Institute, Boston
Beth Israel Deaconess Medical Center, Boston
Massachusetts General Hospital, Cambridge
Cancer Institute of New Jersey, New Brunswick
Genzyme, a Sanofi Company
INDUSTRY