Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
This study has been completed.
Sponsor:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01158079
First received: December 11, 2009
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: ALN-VSP02 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Alnylam Pharmaceuticals:
Primary Outcome Measures:
- Collect long term ALN-VSP02 safety data [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
Secondary Outcome Measures:
- Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]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 [ Time Frame: Every 3 - 6 months ] [ Designated as safety issue: No ]Evaluations will take place every 3-6 months until disease progression
| Enrollment: | 7 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
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 arrhythmia.
- Patient has clinically significant cerebrovascular disease.
- Patient has a seizure disorder not controlled on medication.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158079
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158079
Locations
| United States, Arizona | |
| TGen Clinical Research Service at Scottsdale Healthcare | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Karmanos Cancer Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| Spain | |
| Hospital Virgen del Rocio | |
| Seville, Andalucia, Spain, 41013 | |
| Hospital Universitario Vall d'Hebron | |
| Barcelona, Catalonia, Spain, 08035 | |
| Hospital Clinico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
| Study Director: | Akshay Vaishnaw, MD PhD | Alnylam Pharmaceuticals |
More Information
| Responsible Party: | Alnylam Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01158079 History of Changes |
| Other Study ID Numbers: | ALN-VSP02-002 |
| Study First Received: | December 11, 2009 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Food and Drug Administration Spain: Spanish Agency of Medicines |
Keywords provided by Alnylam Pharmaceuticals:
|
Liver Solid Tumors Advanced Solid Tumors with Liver Involvement |
ClinicalTrials.gov processed this record on September 27, 2016