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

October 11, 2012 updated by: Alnylam Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Andalucia
      • Seville, Andalucia, Spain, 41013
        • Hospital Virgen del Rocío
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitario Vall d'Hebron
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • TGEN Clinical Research Service at Scottsdale Healthcare
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect long term ALN-VSP02 safety data
Time Frame: Throughout the study
Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
Throughout the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)
Time Frame: Every 2 months
Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event
Every 2 months
Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
Time Frame: Every 3 - 6 months
Evaluations will take place every 3-6 months until disease progression
Every 3 - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ALN-VSP02-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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