Antitumor-B KAC PK Study

NCT05452408 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IIT-WONG-ATB-KAC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antitumor B KAC; Antitumor 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 KAC DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Clinical stage II-IVA (as defined by the AJCC, 8th Edition) and amenable to surgical resection.
• New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
• History and physical examination by an otolaryngologist and medical oncologist within 30 calendar days of study registration.
• Study agent administration should start within seven days of registration.
• Patient must receive administration of study agent for a minimum of seven days.
• ECOG Performance status \< 2.
• Age ≥ 18 years.
• CBC/differential obtained within 30 calendar days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.);
• Adequate renal and hepatic function within 30 calendar days prior to registration, defined as follows:
• Serum creatinine \< 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula:
• CrCl male = \[(140 - age) x (weight in kg)\], \[(Serum Cr mg/dL) x (72)\] CrCl female = 0.85 x (CrCl male)
• Total bilirubin \< 2 x the institutional ULN within 30 calendar days prior to registration.

You may not qualify if:

• History of active liver disease.
• Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
• Concurrent use of any medicinal botanical, natural, or other herbal compound/s that the study PI believes could potentially have an impact on the results/objectives of this study.
• Planned subtotal or debulking surgery, as determined by enrolling physician determination, is not permissible.
• Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy for oral SCC is permissible if disease free for one year since prior oral cancer treatment and free of significant late radiation effects.
• Severe active comorbidity, such as uncontrolled cardiac disease, infection, severe COPD.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Stuart J. Wong, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

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 (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)