Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for this cancer. 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 if the combination of imexon plus docetaxel is safe and effective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
USC Norris Cotton Cancer Center
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mary Crowley Research Center
Dallas, Texas, United States
Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology.
Time frame: every 6 weeks
Progression-free survival (PFS), as measured from the date of registration to the date of recorded disease progression (PD) or death from any cause.
Time frame: throughout the study
Overall survival, as measured from the date of registration to the date of death from any cause.
Time frame: throughout the study
Stable disease rate at 2 months.
Time frame: 2 months
Survival at 1-year.
Time frame: 1 year
Duration of response and stable disease.
Time frame: throughout the study
Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.)
Time frame: throughout the study
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