drugset / Trial / NCT00356460
Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2009-05
- Completion
- 2009-05
Publications
- Morris JC, Tan AR, Olencki TE, Shapiro GI, Dezube BJ, Reiss M, Hsu FJ, Berzofsky JA, Lawrence DP. Phase I study of GC1008 (fresolimumab): a human anti-transforming growth factor-beta (TGFbeta) monoclonal antibody in patients with advanced malignant melanoma or renal cell carcinoma. PLoS One. 2014 Mar 11;9(3):e90353. doi: 10.1371/journal.pone.0090353. eCollection 2014.
- Berzofsky JA, Wood LV, Terabe M. Cancer vaccines: 21st century approaches to harnessing an ancient modality to fight cancer. Expert Rev Vaccines. 2013 Oct;12(10):1115-8. doi: 10.1586/14760584.2013.836906. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fresolimumab | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 15 mg/kg | Intravenous |