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Brief Title: Antitumor-B KAC PK Study
Official Title: PK Analysis of Antitumor B KAC in Patients With Oral Cancer
Study ID: NCT05452408
Brief Summary: Study Design: 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.
Detailed Description: Study Rationale: Establishing the PK profile for antitumor B key active components (ATB-KAC) is a critical initial step before future clinical trials can be performed that examine anticancer and cancer preventive effects of ATB-KAC. Study Intervention Description: Study participants will take the natural botanical compound ATB-KAC during a short window (seven to 28 days). Participants will provide blood samples and saliva samples during ATB-KAC administration and a portion of the initial tumor biopsy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Stuart J. Wong, MD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR