Phase II Trial Of PS-341 In Metastatic Breast Cancer
PRIMARY OBJECTIVES:
I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic
breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in
these women.
II. Determine the toxicity profile and tolerability of this drug in these women.
III. Determine the pharmacodynamics of this drug in these women.
OUTLINE:
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12
months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (CR + PR)
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
Up to 24 months
No
Massimo Cristofanilli
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2012-02422
NCT00025584
August 2001
Name | Location |
---|---|
M D Anderson Cancer Center | Houston, Texas 77030 |