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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

Sponsor
Alnylam Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00882180
Collaborator
(none)
41
Enrollment
10
Locations
29
Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Mar 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability of intravenous ALN-VSP02 [up to 16 weeks (4 cycles)]

Secondary Outcome Measures

  1. Plasma and urine PK of ALN-VSP02 [8 weeks (two cycles)]

  2. Assess preliminary evidence of antitumor/antiangiogenic activity [Up to 16 weeks (4 cycles)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 TGen Clinical Research Service at Scottsdale Healthcare Scottsdale Arizona United States 85258
2 Massachusetts General Hospital Boston Massachusetts United States 02114
3 Dana Farber Cancer Institute Boston Massachusetts United States 02115
4 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
5 Karmanos Cancer Center Detroit Michigan United States 48201
6 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
7 Sarah Cannon Research Institute Nashville Tennessee United States 37203
8 Hospital Virgen del Rocio Seville Andalucia Spain 41013
9 Hospital Universitario Vall d'Hebron Barcelona Catalonia Spain 08035
10 Hospital Clinico Universitario de Valencia Valencia Spain 46010

Sponsors and Collaborators

  • Alnylam Pharmaceuticals

Investigators

  • Study Director: Akshay Vaishnaw, MD PhD, Alnylam Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00882180
Other Study ID Numbers:
  • ALN-VSP02-001
First Posted:
Apr 16, 2009
Last Update Posted:
Aug 24, 2011
Last Verified:
Aug 1, 2011
Keywords provided by Alnylam Pharmaceuticals
Liver
Solid Tumors
Advanced Solid Tumors with Liver Involvement
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 24, 2011