Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma
PRIMARY OBJECTIVES:
I. Proportion of confirmed tumor responses.
SECONDARY OBJECTIVES:
I. To evaluate the confirmed and objective response rate. II. To assess patient outcome as
estimated by duration of response, time to disease progression, and survival.
III. To evaluate the adverse event rates associated with PS-341 in this population.
IV. To explore the relationships between laboratory correlates (eg. IHC) and patient outcome
(eg p53 and disease progression).
V. To evaluate alterations in laboratory correlates from pre-treatment measurements (ie, pre
and post treatment). The following immunohistochemistry (IHC) assays will be performed: IHC
of p53, IHC of p21, IHC of p27, IHC of NFkB, IHC of Ki67.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years from study entry.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart
Ninety-five percent confidence intervals for the true success proportion will be calculated.
Up to 36 weeks (12 courses)
No
George Kim
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
NCI-2012-02806
NCT00077441
April 2005
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |