A Phase I/II Study of Nelfinavir in Liposarcoma
I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.
II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single
agent and to describe the toxicities at each does studied.
III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and
progression free survival in patients with liposarcoma treated with nelfinavir.
V. To evaluate the expression and activity of certain proteins in the tumors of patients
entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1,
p21, NFkappaB, caspase 3).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (Phase II)
After 3 cycles of treatment
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope Medical Center||Duarte, California 91010|
|South Pasadena Cancer Center||South Pasadena, California 91030|