NCT04278989

Inhibition of Oral Tumorigenesis by Antitumor B

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a window of opportunity study of Anti-tumor B (ATB). Anti-tumor B is a botanical agent composed of six Chinese herbs: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera.

Detailed description

This study began as a randomized study and was amended to an open label, single arm study. Upon initiating study treatment, patients will start taking the study drug. The duration of treatment will depend upon scheduling of their surgery--typically from the time surgery is scheduled it will be seven to 28 days. Four (300 mg) pills will be taken three times per day until the evening prior to surgery. The primary endpoint is to determine the antiproliferative effects of ATB as determined by tumor Ki-67 in baseline tumor biopsy compared to resected control tumor tissue from untreated subjects. The control group is a mixture of contemporaneous placebo patients plus matched control patients.

Conditions

• Squamous Cell Cancer of the Oral Cavity

Interventions

Type	Name	Description
DRUG	Anti-tumor B	1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).

Timeline

• Start date: 2022-04-22
• Primary completion: 2025-05-19
• Completion: 2025-06-05
• First posted: 2020-02-20
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study