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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882180
• Other study ID #: ALN-VSP02-001
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2009
• Last updated: August 23, 2011
• Start date: March 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Alnylam Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• ALN-VSP02
IV infusion administered every two weeks

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebron	Barcelona	Catalonia
Spain	Hospital Virgen del Rocio	Seville	Andalucia
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	TGen Clinical Research Service at Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of intravenous ALN-VSP02		up to 16 weeks (4 cycles)	Yes
Secondary	Plasma and urine PK of ALN-VSP02		8 weeks (two cycles)	No
Secondary	Assess preliminary evidence of antitumor/antiangiogenic activity		Up to 16 weeks (4 cycles)	No