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NCT03440450 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
A Phase 1 study of Advanced Solid Tumors and Biliary Tract Cancer, sponsored by Fujifilm Pharmaceuticals U.S.A..
- Active
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 7
- Study locations
NCT03440450: Active Phase 1 study of Advanced Solid Tumors and Biliary Tract Cancer, sponsored by Fujifilm Pharmaceuticals U.S.A..
NCT03440450 is a Phase 1 study of Advanced Solid Tumors and Biliary Tract Cancer that is active but no longer recruiting, run by Fujifilm Pharmaceuticals U.S.A.. The registered enrollment target is 90 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (55% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03440450, a Phase 1 study of Advanced Solid Tumors and Biliary Tract Cancer, is active but no longer recruiting, sponsored by Fujifilm Pharmaceuticals U.S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 7
- Study locations
Study 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
Primary Outcome
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
Conditions Studied
Interventions
- DRUG FF-10832 Gemcitabine Liposome Injection
Study Locations (7)
Arizona
- Honor Health Research Institute - Scottsdale
- University of Arizona Cancer Center - Tucson
California
- Hoag Memorial Hospital Comprehensive Cancer Center - Newport Beach
Colorado
- Sarah Cannon Research Institute - Denver
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- MD Anderson Cancer Research Center - Houston
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT03440450 still lists
NCT03440450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which FF-10832 Gemcitabine Liposome Injection is the first listed.
NCT03440450 lists 7 locations in 6 states (Arizona, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03440450 about?
NCT03440450 is a clinical study titled "A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer". 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
What is the current status of trial NCT03440450?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2018-03-22. Estimated completion is 2025-12.
What conditions does trial NCT03440450 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Biliary Tract Cancer.
What interventions are being tested in trial NCT03440450?
The interventions under investigation include: FF-10832 Gemcitabine Liposome Injection (DRUG).
Who is sponsoring clinical trial NCT03440450?
This trial is sponsored by Fujifilm Pharmaceuticals U.S.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03440450 being conducted?
This trial has 7 study locations across Arizona, California, Colorado, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03440450's enrollment target sits among peer trials
90 86th of 144 higher than 58 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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