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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
N/A
Not Enrolling
Both
Solid Tumors

Thank you

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
0-1.

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:

Interventional

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:

Yes

Principal Investigator

Akshay Vaishnaw, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Alnylam Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

ALN-VSP02-002

NCT ID:

NCT01158079

Start Date:

July 2010

Completion Date:

September 2012

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sarah Cannon Research InstituteNashville, Tennessee  37203
Karmanos Cancer CenterDetroit, Michigan  48201
TGEN Clinical Research Service at Scottsdale HealthcareScottsdale, Arizona  85258