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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 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.

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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

Conditions Studied

Advanced Solid Tumors Biliary Tract Cancer

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

FieldValue
Enrollment Target 90 participants
Start Date 2018-03-22
Est. Completion 2025-12
Phase Phase 1

Sponsor

Fujifilm Pharmaceuticals U.S.A.

8 total trials

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What the Registry Record Tells You About NCT03440450

The ClinicalTrials.gov registry entry for NCT03440450 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (55% lower). The listed sponsor is Fujifilm Pharmaceuticals U.S.A., which has 8 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.