Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients with cancer who completed participation in another ALN-VSP02 clinical study. The primary objective of this study is to collect long term safety data.

Key facts

Study ID

NCT01158079

Run by

Alnylam Pharmaceuticals

People needed

7

Starts

2010-07-01

Expected to finish

2012-09-01

Last updated by the study team

2012-10-12

Who can join

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

You may qualify if…

• Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Patient has adequate hematologic, liver, and renal function.

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 arrhythmia.
• Patient has clinically significant cerebrovascular disease.
• Patient has a seizure disorder not controlled on medication.

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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