drugset / Trial / NCT00801177

Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy

NCT00801177

Phase 1 Completed 60 enrolled Eli Lilly and Company
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

EvaluationDrugModalityDoseRoute
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

Indications