Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

Solid Tumors Clinical Trial

Official title:

A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158079
• Other study ID #: ALN-VSP02-002
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2009
• Last updated: October 11, 2012
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• 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

This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients with cancer who completed participation in another ALN-VSP02 clinical study. The primary objective of this study is to collect long term safety data.

Description:

Study ALN-VSP02 is an extension study for previously conducted ALN-VSP02 studies. The study is being conducted to allow for continued ALN-VSP02 therapy for patients who completed participation in an ALN-VSP02 clinical study, achieved clinical benefit with ALN-VSP02 (i.e., disease response of stable disease or better), and, in the Investigator's opinion, may benefit from continuation of ALN-VSP02 therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.

2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

3. Patient has adequate hematologic, liver, and renal function.

Exclusion Criteria:

1. Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin > 325 mg/day or other platelet inhibitory agents.

2. Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia.

3. Patient has clinically significant cerebrovascular disease.

4. Patient has a seizure disorder not controlled on medication.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• ALN-VSP02
The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study

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	Collect long term ALN-VSP02 safety data	Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.	Throughout the study	Yes
Secondary	Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)	Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event	Every 2 months	No
Secondary	Evaluate preliminary evidence of antitumor activity/antiangiogenic activity	Evaluations will take place every 3-6 months until disease progression	Every 3 - 6 months	No