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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of intravenous ALN-VSP02

Outcome Time Frame:

up to 16 weeks (4 cycles)

Safety Issue:

Yes

Principal Investigator

Akshay Vaishnaw, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Alnylam Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

ALN-VSP02-001

NCT ID:

NCT00882180

Start Date:

March 2009

Completion Date:

August 2011

Related Keywords:

  • Solid Tumors
  • Liver
  • Solid Tumors
  • Advanced Solid Tumors with Liver Involvement
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sarah Cannon Research InstituteNashville, Tennessee  37203
Karmanos Cancer CenterDetroit, Michigan  48201
TGEN Clinical Research Service at Scottsdale HealthcareScottsdale, Arizona  85258