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

NCT00882180 | Completed Phase 1

• 1 other identifier: ALN-VSP02-001
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 10

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.

Conditions

Solid Tumors

Keywords

Liver; Solid Tumors; Advanced Solid Tumors with Liver Involvement

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of intravenous ALN-VSP02

  up to 16 weeks (4 cycles)

Secondary Outcomes (2)

• Plasma and urine PK of ALN-VSP02

  8 weeks (two cycles)

• Assess preliminary evidence of antitumor/antiangiogenic activity

  Up to 16 weeks (4 cycles)

Interventions

ALN-VSP02 DRUG

IV infusion administered every two weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (10)

TGen Clinical Research Service at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Hospital Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Study Officials

• Akshay Vaishnaw, MD PhD

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 24, 2011

Record last verified: 2011-08

Locations

ES (3); US (7)