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Antitumor-B KAC PK Study

NCT05452408 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of the Oral Cavity

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Stuart J. Wong, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452408 on ClinicalTrials.gov