Trials Sponsors Conditions Drugs Pricing

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Keywords

Antitumor B KACAntitumor B Key Active Components

Outcome Measures

Primary Outcomes (4)

Area under the Curve (AUC) for Saliva
The AUC will be calculated. The calculation will be mg/ml X hour.
predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1
Area under the Curve for Plasma
The AUC will be calculated. The calculation will be mg/ml X hour.
predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1
Cmax for Saliva
The Cmax will be calculated. The calculation will be ng/ml.
Day 1
Cmax for Plasma
The Cmax will be calculated. The calculation will be ng/ml.
Day 1

Study Arms (1)

Antitumor B KAC

EXPERIMENTAL

ATB will be administered on an outpatient basis.

Drug: Antitumor B KAC

Interventions

Antitumor B KACDrug

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.

Antitumor B KAC

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical diagnosis of oral cavity squamous cell cancer.
Patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within seven days of registration in order to continue study agent administration.

Sponsors & Collaborators

Medical College of Wisconsin
Otherlead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

Stuart J. Wong, MD
Medical College of Wisconsin
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Stopped

Antitumor-B KAC PK Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Antitumor B KAC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Antitumor B KAC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations