Status:

COMPLETED

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

Lead Sponsor:

Alnylam Pharmaceuticals

Conditions:

Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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...

Detailed Description

Study ALN-VSP02 is an extension study for previously conducted ALN-VSP02 studies. The study is being conducted to allow for continued ALN-VSP02 therapy for patients who completed participation in an A...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT01158079

Start Date

July 1 2010

End Date

September 1 2012

Last Update

October 12 2012

Active Locations (10)

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Page 1 of 3 (10 locations)

1

TGen Clinical Research Service at Scottsdale Healthcare

Scottsdale, Arizona, United States, 85258

2

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

3

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

4

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

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