- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158079
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
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
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Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia
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Andalucia
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Seville, Andalucia, Spain, 41013
- Hospital Virgen del Rocío
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Catalonia
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Barcelona, Catalonia, Spain, 08035
- Hospital Universitario Vall d'Hebron
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Arizona
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Scottsdale, Arizona, United States, 85258
- TGEN Clinical Research Service at Scottsdale Healthcare
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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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:
- Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Patient has adequate hematologic, liver, and renal function.
Exclusion Criteria:
- Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin > 325 mg/day or other platelet inhibitory agents.
- Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia.
- Patient has clinically significant cerebrovascular disease.
- 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
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Patients remain on treatment until disease progression or an adverse event.
Adverse events are assessed throughout treatment.
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Throughout the study
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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
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Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event
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Every 2 months
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Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
Time Frame: Every 3 - 6 months
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Evaluations will take place every 3-6 months until disease progression
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Every 3 - 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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