Solid Tumors
Conditions
Keywords
Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement
Brief summary
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.
Interventions
DRUGALN-VSP02
IV infusion administered every two weeks
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy * Patient has measurable tumor in the liver * At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 * Patient has adequate hematologic, liver, and renal function * Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV) * Patient has a life expectancy \> 12 weeks
Exclusion criteria
* Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin \> 325 mg/day or other platelet inhibitory agents * Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrythmia * Patient has known active brain or leptomeningeal metastases * Patient has clinically significant cerebrovascular disease * Patient has a seizure disorder not controlled on medication * Patient has a known or suspected viral, parasitic or fungal infection * Patient previously experienced a severe reaction to a liposomal product * Patient has a known hypersensitivity to lipid products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of intravenous ALN-VSP02 | up to 16 weeks (4 cycles) |
Secondary
| Measure | 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) |
Countries
Spain, United States
Outcome results
None listed