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

Alnylam Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: ALN-VSP02

Study type: Interventional

Funder types: Industry

Identifiers

NCT01158079

ALN-VSP02-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)