The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
IV infusion administered every two weeks
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Safety and Tolerability of intravenous ALN-VSP02
Time frame: up to 16 weeks (4 cycles)
Plasma and urine PK of ALN-VSP02
Time frame: 8 weeks (two cycles)
Assess preliminary evidence of antitumor/antiangiogenic activity
Time frame: Up to 16 weeks (4 cycles)
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Hospital Virgen del Rocio
Seville, Andalusia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain