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Previous Phase 1 studies have shown the acceptable safety profile of ganitumab-a fully human monoclonal antibody to insulin-like growth factor Type 1 receptor-in patients with advanced solid tumors. However, ganitumab 20 mg/kg in combination with gemcitabine had not been administered to patients with metastatic pancreatic cancer. To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of ganitumab 20 mg/kg combined with gemcitabine 1000 mg/m(2) as first-line therapy in patients with metastatic pancreatic cancer, we conducted a Phase 1b study.

japanese journal of clinical oncology

Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Ganitumab, an Investigational Fully Human Monoclonal Antibody to Insulin-like Growth Factor Type 1 Receptor, Combined with Gemcitabine as First-line Therapy in Patients with Metastatic Pancreatic Cancer: A Phase 1b Study