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

April 15, 2009
August 23, 2011
March 2009
July 2011   (final data collection date for primary outcome measure)
Safety and Tolerability of intravenous ALN-VSP02 [ Time Frame: up to 16 weeks (4 cycles) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00882180 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: ALN-VSP02
IV infusion administered every two weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT00882180
ALN-VSP02-001
No
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP