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ACTIVE NOT RECRUITING
NCT03440450
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

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