Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Carcinoma, Renal CellMelanoma
Interventions
BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

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)

Trial Locations (6)

20892

National Cancer Institute (NCI), Bethesda

43210

Ohio State University, Columbus

02115

Dana Farber/Harvard Cancer Center, Dana Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02114

Massachusetts General Hospital, Cambridge

08901

Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00356460 - Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma | Biotech Hunter | Biotech Hunter