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

Name: A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer — clinical trial record (NCT03440450)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 1

SponsorFujifilm Pharmaceuticals U.S.A., Inc.

Started2018-03-22

View on ClinicalTrials.gov ↗

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

Amendment history 2 changes detected by DataLookout

2026-09-03

Primary completion pushed: 2025-05-15 → 2026-10

2026-09-03

Completion pushed: 2025-12 → 2027-03

Trial Details

NCT Number	NCT03440450
Lead Sponsor	Fujifilm Pharmaceuticals U.S.A., Inc.
Conditions	Advanced Solid Tumors, Biliary Tract Cancer
Enrollment	90 participants
Start Date	2018-03-22
Primary Completion	2026-10 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-09-02