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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-VSP02 | Drug | IV infusion administered every two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of intravenous ALN-VSP02 | up to 16 weeks (4 cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine PK of ALN-VSP02 | 8 weeks (two cycles) | |
| Assess preliminary evidence of antitumor/antiangiogenic activity | Up to 16 weeks (4 cycles) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akshay Vaishnaw, MD PhD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Service at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
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| Massachusetts General Hospital |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Hospital Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |