NCT03459729|CompletedEarly Phase 1ResultsDMCFDA Drug
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PK Analysis of Antitumor B in Patients With Oral Cancer
Sponsor study identifier
Secondary identifiers
NIH
interventional
6
1 country
1
Study Start
August 24, 2021
Actual (reported)Primary Completion
February 15, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2018
Actual (reported)March 9, 2018
Actual (reported)August 24, 2021
Actual (reported)February 15, 2022
Actual (reported)February 16, 2022
Actual (reported)April 21, 2023
Actual (reported)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.
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.
Day 1
Maximum Concentration (Cmax) of Matrine in Saliva
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Day 1
Maximum Concentration of Matrine in Plasma
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Day 1
ATB will be administered on an outpatient basis.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
Stuart Wong, MD
Medical College of Wisconsin
6 participants (actual enrollment reported by the registry).
First Submitted
March 1, 2018
First Posted
March 9, 2018
Study Start
August 24, 2021
Actual (reported)Contribution of Residual Tumour DNA Testing on the Surgical Bed
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.
Day 1
Area Under the Curve (AUC) for Maackiain in Plasma
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.
Day 1
Maximum Concentration of Maackiain in Saliva
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Day 1
Maximum Concentration of Maackiain in Plasma
This measure is the maximum concentration observed. The results will be reported in ng/ml.
Day 1
Contact the study team to confirm eligibility.
Primary Completion
February 15, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)Last Updated
January 16, 2025
Results First Posted
April 21, 2023
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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