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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 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-VSP02 | Drug | The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate preliminary evidence of antitumor activity/antiangiogenic activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akshay Vaishnaw, MD PhD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Service at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
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Evaluations will take place every 3-6 months until disease progression |
| Every 3 - 6 months |
| Massachusetts General Hospital |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Hospital Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |