Last updated on April 2019

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

Brief description of study

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.

Detailed Study Description

Dose-escalation Phase Eligible patients will receive FF-10832. In the first cohort, FF-10832 1.2 mg/mPP2PP will be administered intravenously (IV) on Days 1 and 15 of each 28-day cycle, 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.

Clinical Study Identifier: NCT03440450

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