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

NCT01158079 | Completed Phase 1

• 1 other identifier: ALN-VSP02-002
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 10

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.

Conditions

Solid Tumors

Keywords

Liver; Solid Tumors; Advanced Solid Tumors with Liver Involvement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)

  Every 2 months

• Evaluate preliminary evidence of antitumor activity/antiangiogenic activity

  Every 3 - 6 months

Interventions

ALN-VSP02 DRUG

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

Eligibility Criteria

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

You may qualify if:

• Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Patient has adequate hematologic, liver, and renal function.

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 arrhythmia.
• Patient has clinically significant cerebrovascular disease.
• Patient has a seizure disorder not controlled on medication.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: July 8, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

US (7); ES (3)