Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
IV variable dosages, days 1-5 every 21 days for duration of study
IV once every 21 days for duration of study
Investigational Site 008
Houston, Texas, United States
Determine the tolerability
Time frame: duration of study
determine the maximally tolerated dose (MTD)
Time frame: duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
Time frame: duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
Time frame: cycle 1
Record any objective tumor responses which may occur
Time frame: duration of study
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