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A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
Summary
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors including biliary tract cancer
Official title: A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2018-03-22
Completion Date
2025-12
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Locations (7)
Honor Health Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Hoag Memorial Hospital Comprehensive Cancer Center
Newport Beach, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Research Center
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States