This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Intravenous administration of Ceramide NanoLiposome
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.
Time frame: 24 months
Recommended phase II dose
Time frame: 24 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
Peak plasma concentration (Cmax)
Time frame: 24 months
Time to maximum plasma concentration (Tmax)
Time frame: 24 months
Ceramide NanoLiposome half-life (t1/2)
Time frame: 24 months
Objective response rate per RECIST v1.1
Time frame: 24 months
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