Clinical trial NCT00882180: Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
Official title: A Multi-Center, Open Label, Phase 1 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Liver
Solid Tumors
Advanced Solid Tumors with Liver Involvement
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of intravenous ALN-VSP02
timeFrame: up to 16 weeks (4 cycles)
Secondary outcomes:
measure: Plasma and urine PK of ALN-VSP02
timeFrame: 8 weeks (two cycles)
measure: Assess preliminary evidence of antitumor/antiangiogenic activity
timeFrame: Up to 16 weeks (4 cycles)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: TGen Clinical Research Service at Scottsdale Healthcare
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Seville
country: Spain
facility: Hospital Virgen del Rocio
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
state: Catalonia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Akshay Vaishnaw, MD PhD
role: STUDY_DIRECTOR
References: