MedTrace Logo

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

NCT03459729 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-01-16

Study results available
· View outcomes & findings →

Summary

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

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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Stuart Wong, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2022-02-15
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03459729 on ClinicalTrials.gov