Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alnylam Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
