Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

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).

Antitumor B

Stuart Wong, MD

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.

Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer

PK Analysis of Antitumor B in Patients With Oral Cancer

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.

This measure is the maximum concentration observed. The results will be reported in ng/ml.

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.

National Cancer Institute (NCI)

Medical College of Wisconsin

Professor

ATB will be administered on an outpatient basis.

Antitumor B: 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).

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Area Under the Curve (AUC) for Matrine in Saliva

Area Under the Curve for Matrine in Plasma

Maximum Concentration (Cmax) of Matrine in Saliva

Maximum Concentration of Matrine in Plasma

Area Under the Curve (AUC) for Maackiain in Saliva

Area Under the Curve (AUC) for Maackiain in Plasma

Maximum Concentration of Maackiain in Saliva

Maximum Concentration of Maackiain in Plasma

Antitumor B (ATB) will be administered on an outpatient basis.

Antitumor B: 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).

Overall Study

Spots Global Cancer Trial Database for Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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