drugset / Trial / NCT00801177
Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy
Non-randomizedParallel-groupOpen-label
Summary
The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to determine the best dose of IMC-11F8 to give to patients.
Timeline
- Start
- 2004-11
- Primary completion
- 2007-02
- Completion
- 2007-02
Publications
- Results Kuenen B, Witteveen E, Ruijter R, Ervin-Haynes A, Tjin-A-ton M, Fox F, et al. A phase I study of IMC-11F8, a fully human anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody in patients with solid tumors. Interim results. [abstract 3024 and poster presentation]. American Society of Clinical Oncology Annual Meeting. 2006 June 2-6; Atlanta, GA.
- Results Kuenen B, Witteveen PO, Ruijter R, Tjin-A-Ton M, Youssoufian H, Rowinsky E, et al. A phase I study of IMC-11F8, a recombinant human anti-epidermal growth factor receptor IgG1 monoclonal antibody in patients with solid tumors. [abstract B52 and poster presentaton] International Conference on Molecular Targets and Cancer Therapeutics 2007 Oct 22-26; San Francisco, CA.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Necitumumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Necitumumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Necitumumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Necitumumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Necitumumab | Monoclonal antibody | 800 mg | Intravenous |
| Subject | Necitumumab | Monoclonal antibody | 1000 mg | Intravenous |