A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Similar to a phase 0 study, the trial design permits examination of the biologic effects of an agent; in this study pharmacokinetic properties will be examined.
Study Intervention Description: Study participants will take the natural botanical compound ATB during a short window (7 to 28 days). Participants will provide blood samples, and saliva samples during Anti-tumor B (ATB) administration and a portion of the initial tumor biopsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Study participants will take the natural botanical compound ATB during a short window (seven to 28 days). It will be administered at a dose of 1200 mg three times per day (roughly spaced every 8 hours).
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Area Under the Curve (AUC) for Matrine in Saliva
The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.
Time frame: Day 1
Area Under the Curve for Matrine in Plasma
The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.
Time frame: Day 1
Maximum Concentration (Cmax) of Matrine in Saliva
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Time frame: Day 1
Maximum Concentration of Matrine in Plasma
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Time frame: Day 1
Area Under the Curve (AUC) for Maackiain in Saliva
The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.
Time frame: Day 1
Area Under the Curve (AUC) for Maackiain in Plasma
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The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.
Time frame: Day 1
Maximum Concentration of Maackiain in Saliva
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Time frame: Day 1
Maximum Concentration of Maackiain in Plasma
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Time frame: Day 1