Solid Tumors Clinical Trial
Official title:
A Multi-Center, Open Label, Phase 1 Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 in Patients With Advanced Solid Tumors With Liver Involvement
The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy - Patient has measurable tumor in the liver - At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 - Patient has adequate hematologic, liver, and renal function - Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV) - Patient has a life expectancy > 12 weeks 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 arrythmia - Patient has known active brain or leptomeningeal metastases - Patient has clinically significant cerebrovascular disease - Patient has a seizure disorder not controlled on medication - Patient has a known or suspected viral, parasitic or fungal infection - Patient previously experienced a severe reaction to a liposomal product - Patient has a known hypersensitivity to lipid products |
Allocation: Non-Randomized, Endpoint Classification: Safety 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 | Safety and Tolerability of intravenous ALN-VSP02 | up to 16 weeks (4 cycles) | Yes | |
Secondary | Plasma and urine PK of ALN-VSP02 | 8 weeks (two cycles) | No | |
Secondary | Assess preliminary evidence of antitumor/antiangiogenic activity | Up to 16 weeks (4 cycles) | No |
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