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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01158079
First received: December 11, 2009
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Tumors
 Drug: ALN-VSP02
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alnylam Pharmaceuticals:

Primary Outcome Measures:
  • Collect long term ALN-VSP02 safety data [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
    Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.


Secondary Outcome Measures:
  • Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
    Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event

  • Evaluate preliminary evidence of antitumor activity/antiangiogenic activity [ Time Frame: Every 3 - 6 months ] [ Designated as safety issue: No ]
    Evaluations will take place every 3-6 months until disease progression


Enrollment: 7
Study Start Date: July 2010
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158079

Locations
United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Spain
Hospital Virgen del Rocio
Seville, Andalucia, Spain, 41013
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01158079     History of Changes
Other Study ID Numbers: ALN-VSP02-002
Study First Received: December 11, 2009
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines

Keywords provided by Alnylam Pharmaceuticals:
Liver
Solid Tumors
Advanced Solid Tumors with Liver Involvement

ClinicalTrials.gov processed this record on May 19, 2013