Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: ALN-VSP02

Study type

Interventional

Funder types

Industry

Identifiers

NCT00882180

ALN-VSP02-001

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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