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

NCT03440450 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-18

No results posted yet for this 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

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

Sponsors & Collaborators

  • Fujifilm Pharmaceuticals U.S.A., Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2025-05-15
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440450 on ClinicalTrials.gov