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

Phase 1

Completed

• Conditions: Solid Tumors

• Registration Number: NCT01158079
• Lead Sponsor: Alnylam Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-12-11
• Study Start: 2010-07
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-08
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Collect long term ALN-VSP02 safety data	Throughout the study	Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.

Secondary Outcome Measures

Name	Time	Method
Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)	Every 2 months	Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event
Evaluate preliminary evidence of antitumor activity/antiangiogenic activity	Every 3 - 6 months	Evaluations will take place every 3-6 months until disease progression

Trial Locations

Locations (10)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Hospital Virgen del Rocio; 🇪🇸 Seville, Andalucia, Spain

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

TGen Clinical Research Service at Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States