Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
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ClinicalTrials.gov Identifier: NCT01158079 |
Recruitment Status
:
Completed
First Posted
: July 8, 2010
Last Update Posted
: October 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: ALN-VSP02 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | September 2012 |
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Drug: ALN-VSP02
- 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.
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158079
United States, Arizona | |
TGen Clinical Research Service at Scottsdale Healthcare | |
Scottsdale, Arizona, United States, 85258 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
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 |
Study Director: | Akshay Vaishnaw, MD PhD | Alnylam Pharmaceuticals |
Responsible Party: | Alnylam Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01158079 History of Changes |
Other Study ID Numbers: |
ALN-VSP02-002 |
First Posted: | July 8, 2010 Key Record Dates |
Last Update Posted: | October 12, 2012 |
Last Verified: | October 2012 |
Keywords provided by Alnylam Pharmaceuticals:
Liver Solid Tumors Advanced Solid Tumors with Liver Involvement |