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

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

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

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 ALN-VSP02 clinical study, achieved clinical benefit with ALN-VSP02
(i.e., disease response of stable disease or better), and, in the Investigator's opinion,
may benefit from continuation of ALN-VSP02 therapy.

Inclusion Criteria:

1. Patient has completed a previous ALN-VSP02 study, and is deemed to have stable
disease or better.

2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of

3. Patient has adequate hematologic, liver, and renal function.

Exclusion Criteria:

1. Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin >
325 mg/day or other platelet inhibitory agents.

2. Patient has clinically significant cardiovascular disease or uncontrolled serious
cardiac arrhythmia.

3. Patient has clinically significant cerebrovascular disease.

4. Patient has a seizure disorder not controlled on medication.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Collect long term ALN-VSP02 safety data

Outcome Description:

Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.

Outcome Time Frame:

Throughout the study

Safety Issue:


Principal Investigator

Akshay Vaishnaw, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Alnylam Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

September 2012

Related Keywords:

  • Solid Tumors
  • Liver
  • Solid Tumors
  • Advanced Solid Tumors with Liver Involvement



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana Farber Cancer Institute Boston, Massachusetts  02115
Sarah Cannon Research Institute Nashville, Tennessee  37203
Karmanos Cancer Center Detroit, Michigan  48201
TGEN Clinical Research Service at Scottsdale Healthcare Scottsdale, Arizona  85258