NCT01181245

A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objectives * Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib * Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib

Conditions

• Locally Advanced or Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	FG-3019	3mg/kg IV, 10mg/kg IV, 15mg/kg IV, 25mg/kg, 35mg/kg IV, 45mg/kg IV - Biweekly, 35/17.5mg/kg, 45/22.5 mg/kg - Weekly

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2010-08-13
• Last updated: 2014-08-06

Locations

7 sites across 1 country: United States