Solid Tumors Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | September 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Vall d'Hebron | Barcelona | Catalonia |
Spain | Hospital Virgen del Rocio | Seville | Andalucia |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Karmanos Cancer Center | Detroit | Michigan |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | TGen Clinical Research Service at Scottsdale Healthcare | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Alnylam Pharmaceuticals |
United States, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Collect long term ALN-VSP02 safety data | Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment. | Throughout the study | Yes |
Secondary | Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST) | Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event | Every 2 months | No |
Secondary | Evaluate preliminary evidence of antitumor activity/antiangiogenic activity | Evaluations will take place every 3-6 months until disease progression | Every 3 - 6 months | No |
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