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

• Sponsor: Alnylam Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01158079
• Collaborator: (none)
• Enrollment: 7
• Locations: 10
• Duration (Months): 26.1
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: ALN-VSP02	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Evaluate preliminary evidence of antitumor activity/antiangiogenic activity [Every 3 - 6 months]

   Evaluations will take place every 3-6 months until disease progression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TGen Clinical Research Service at Scottsdale Healthcare	Scottsdale	Arizona	United States	85258
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Karmanos Cancer Center	Detroit	Michigan	United States	48201
6	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
7	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
8	Hospital Virgen del Rocio	Seville	Andalucia	Spain	41013
9	Hospital Universitario Vall d'Hebron	Barcelona	Catalonia	Spain	08035
10	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010

Sponsors and Collaborators

• Alnylam Pharmaceuticals

Investigators

• Study Director: Akshay Vaishnaw, MD PhD, Alnylam Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alnylam Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01158079
• Other Study ID Numbers: ALN-VSP02-002
• First Posted: Jul 8, 2010
• Last Update Posted: Oct 12, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Alnylam Pharmaceuticals: Liver; Solid Tumors; Advanced Solid Tumors with Liver Involvement

Study Results

No Results Posted as of Oct 12, 2012