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Clinical Trial 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.


Clinical Trial 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 15 patients in a 21 day cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03440450
Study type Interventional
Source Fujifilm Pharmaceuticals U.S.A., Inc.
Contact FPHU Study Coordinator
Email fphucontact@fujifilm.com
Status Recruiting
Phase Phase 1
Start date March 22, 2018
Completion date March 2025

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