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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882180
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : August 24, 2011
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ALN-VSP02 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Intervention Details:
  • Drug: ALN-VSP02
    IV infusion administered every two weeks

Primary Outcome Measures :
  1. Safety and Tolerability of intravenous ALN-VSP02 [ Time Frame: up to 16 weeks (4 cycles) ]

Secondary Outcome Measures :
  1. Plasma and urine PK of ALN-VSP02 [ Time Frame: 8 weeks (two cycles) ]
  2. Assess preliminary evidence of antitumor/antiangiogenic activity [ Time Frame: Up to 16 weeks (4 cycles) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882180

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United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Hospital Virgen del Rocio
Seville, Andalucia, Spain, 41013
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Alnylam Pharmaceuticals
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Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
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Responsible Party: Alnylam Pharmaceuticals Identifier: NCT00882180    
Other Study ID Numbers: ALN-VSP02-001
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011
Keywords provided by Alnylam Pharmaceuticals:
Solid Tumors
Advanced Solid Tumors with Liver Involvement
Additional relevant MeSH terms:
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