NCT03440450

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

A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Dose-escalation Phase: Eligible patients will receive FF-10832 in 28 day or 21 day cycles. Dosing will continue until progression of disease, observation of unacceptable adverse events, intercurrent illness, or changes in the patient's condition that prevents further study participation after discussion between the Investigator and the Medical Monitor. A number of cohorts will be enrolled sufficient to determine the MTD and to identify the RP2D. Expansion Phase: One cohort of biliary tract cancer will enroll up to 18 patients in a 21 day cycle.

Conditions

• Advanced Solid Tumors
• Biliary Tract Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-22
• Primary completion: 2025-05-15
• Completion: 2025-12-01
• First posted: 2018-02-22
• Last updated: 2025-05-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study