NCT05452408

Antitumor-B KAC PK Study

PK Analysis of Antitumor B KAC in Patients with Oral Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
DRUG	Antitumor B KAC	ATB-KAC will be administered at a dose of 720 mg three times per day (roughly spaced every eight hours) as has been studied for ATB-KAC in human oral leukoplakia trials and in esophageal cancer prevention trials. ATB-KAC may be taken with or without food.

Timeline

• Start date: 2026-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-07-11
• Last updated: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study