drugset
drugset / Trial / NCT03440450

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer

NCT03440450 ↗

Phase 1 Active not recruiting 90 enrolled Fujifilm Pharmaceuticals U.S.A., Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2018-03-22
Primary completion
2025-05-15
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1.2 mg/m2 Intravenous
Subject Gemcitabine Small molecule 2.4 mg/m2 Intravenous
Subject Gemcitabine Small molecule 4.8 mg/m2 Intravenous
Subject Gemcitabine Small molecule 8 mg/m2 Intravenous

Indications

biliary tract cancer