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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: ALN-VSP02


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Evaluations will take place every 3-6 months until disease progression | Every 3 - 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement