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

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal antibody in previously treated patients with locally advanced or metastatic renal cell carcinoma or malignant melanoma.

Conditions

• Carcinoma, Renal Cell
• Melanoma

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)

Sponsors & Collaborators

• Genzyme, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United States

Study Locations