A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
18 Years
N/A
Both
Solid Tumors
Trial Information
A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Collect long term ALN-VSP02 safety data
Outcome Description:
Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
Outcome Time Frame:
Throughout the study
Safety Issue:
Yes
Principal Investigator
Akshay Vaishnaw, MD PhD
Investigator Role:
Study Director
Investigator Affiliation:
Alnylam Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
ALN-VSP02-002
NCT ID:
NCT01158079
Start Date:
July 2010
Completion Date:
September 2012
Related Keywords:
- Solid Tumors
- Liver
- Solid Tumors
- Advanced Solid Tumors with Liver Involvement
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Karmanos Cancer Center | Detroit, Michigan 48201 |
| TGEN Clinical Research Service at Scottsdale Healthcare | Scottsdale, Arizona 85258 |
