Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ALN-VSP02

IV infusion administered every two weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
* Patient has measurable tumor in the liver
* At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
* Patient has adequate hematologic, liver, and renal function
* Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Patient has a life expectancy \> 12 weeks

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 arrythmia
* Patient has known active brain or leptomeningeal metastases
* Patient has clinically significant cerebrovascular disease
* Patient has a seizure disorder not controlled on medication
* Patient has a known or suspected viral, parasitic or fungal infection
* Patient previously experienced a severe reaction to a liposomal product
* Patient has a known hypersensitivity to lipid products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No