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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT00882180

Run by

Alnylam Pharmaceuticals

People needed

41

Starts

2009-03-01

Expected to finish

2011-08-01

Last updated by the study team

2011-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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