A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
I. Determine the response rate, time to progression, and survival of patients with advanced
non-small cell lung cancer treated with bortezomib.
II. Determine the toxicity of this drug in these patients. III. Correlate toxicity and
activity of this drug with markers of proteasome inhibition in blood and peripheral
mononuclear cells in these patients.
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 who
received prior bortezomib and achieved at least a partial response of at least 6 months
duration may also receive therapy as above.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate to PS-341 therapy
Up to 4 years
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|