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.
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00882180
First received: April 15, 2009
Last updated: August 23, 2011
Last verified: August 2011
  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 1

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:


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:
    Drug: ALN-VSP02
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014