Solid Tumors
Conditions
Keywords
Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement
Brief summary
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
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.
Interventions
DRUGALN-VSP02
The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect long term ALN-VSP02 safety data | Throughout the study | Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST) | 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 | Every 3 - 6 months | Evaluations will take place every 3-6 months until disease progression |
Countries
Spain, United States
Outcome results
None listed