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
- Conditions
- Locally Advanced or Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT01181245
- Lead Sponsor
- FibroGen
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FG-3019 FG-3019 All subjects are treated with FG-3019
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib Through the end of the study
- Secondary Outcome Measures
Name Time Method Maximal tumor response as determined by RECIST criteria Through the end of the study FG-3019 PK parameters Through the end of the study Time to Progression (TTP) Through the end of the study 6-month, 12-month and overall median survival rates Through the end of the study
Trial Locations
- Locations (7)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Oregon Health Sciences University (OHSU)
🇺🇸Portland, Oregon, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University Hospitals of Cleveland, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States