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

NCT ID: NCT01158079

Last Updated: 2012-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Solid Tumors

Keywords

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Liver Solid Tumors Advanced Solid Tumors with Liver Involvement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ALN-VSP02

The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akshay Vaishnaw, MD PhD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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TGen Clinical Research Service at Scottsdale Healthcare

Scottsdale, Arizona, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Center

Detroit, Michigan, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Hospital Virgen del Rocio

Seville, Andalusia, Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Countries

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United States Spain

Other Identifiers

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ALN-VSP02-002

Identifier Type: -

Identifier Source: org_study_id