Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

This study has been completed.

First Received on April 15, 2009. Last Updated on August 23, 2011 History of Changes

Sponsor:	Alnylam Pharmaceuticals
Information provided by (Responsible Party):	Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00882180

Purpose

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	Intervention	Phase
Solid Tumors	Drug: ALN-VSP02	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Alnylam Pharmaceuticals:

Primary Outcome Measures:

Safety and Tolerability of intravenous ALN-VSP02 [ Time Frame: up to 16 weeks (4 cycles) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma and urine PK of ALN-VSP02 [ Time Frame: 8 weeks (two cycles) ] [ Designated as safety issue: No ]
Assess preliminary evidence of antitumor/antiangiogenic activity [ Time Frame: Up to 16 weeks (4 cycles) ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	March 2009
Study Completion Date:	August 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

IV infusion administered every two weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882180

Locations

United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Spain
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

Investigators

Study Director:

Akshay Vaishnaw, MD PhD

Alnylam Pharmaceuticals

More Information

No publications provided

Responsible Party:	Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00882180 History of Changes
Other Study ID Numbers:	ALN-VSP02-001
Study First Received:	April 15, 2009
Last Updated:	August 23, 2011
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Agency of Medicines

Keywords provided by Alnylam Pharmaceuticals:

Liver
Solid Tumors
Advanced Solid Tumors with Liver Involvement

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012