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:
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

December 11, 2009
October 11, 2012
July 2010
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01158079 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
September 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT01158079
ALN-VSP02-002
No
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
Study Director: Akshay Vaishnaw, MD PhD Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP