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

NCT03459729 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: PRO36718R01CA205633
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anti-tumor B; ACAPHA; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Area Under the Curve (AUC) for Matrine in Saliva

  The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

  Day 1

• Area Under the Curve for Matrine in Plasma

  The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

  Day 1

• Maximum Concentration (Cmax) of Matrine in Saliva

  This measure is the maximum concentration observed. The results will be reported in ng/ml.

  Day 1

• Maximum Concentration of Matrine in Plasma

  This measure is the maximum concentration observed. The results will be reported in ng/ml.

  Day 1

• Area Under the Curve (AUC) for Maackiain in Saliva

  The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

  Day 1

• Area Under the Curve (AUC) for Maackiain in Plasma

  The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

  Day 1

• Maximum Concentration of Maackiain in Saliva

  This measure is the maximum concentration observed. The results will be reported in ng/ml.

  Day 1

• Maximum Concentration of Maackiain in Plasma

  This measure is the maximum concentration observed. The results will be reported in ng/ml.

  Day 1

Study Arms (1)

Antitumor B

EXPERIMENTAL

ATB will be administered on an outpatient basis.

Drug: Antitumor B

Interventions

Antitumor B DRUG

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).

Also known as: Zeng Sheng Ping, ATB, ACAPHA

Antitumor B

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 7 days of registration in order to continue study agent administration.
• Clinical stage II-IVA (as defined by the American Joint Committee on Cancer, 8th Edition \[see Amin, 2017\]) and amenable to surgical resection
• New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of 6 months following previous definite surgery
• History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration
• Study agent administration should start within 7 days of registration
• Patient must receive administration of study agent for a minimum of 7 days
• Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status \< 2.
• Age ≥ 18 years.
• Complete Blood Count (CBC)/differential obtained within 14 calendar days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3;
• Platelets ≥ 100,000 cells/mm\^3;
• 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 14 calendar days prior to registration, defined as follows:
• o Serum creatinine \< 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)

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 impact 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 1 year since prior oral cancer treatment and free of significant late radiation effects.
• Severe active comorbidity such as uncontrolled cardiac disease, infection, severe Chronic Obstructive Pulmonary Disease (COPD).

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.

  PMID: 28094848 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Antitumor B; antitumor A

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Stuart Wong, MD
• Organization: Froedtert and the Medical college of Wisconsin

swong@mcw.edu

414-805-4600

Study Officials

• Stuart Wong, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 9, 2018
• Study Start: August 24, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 16, 2022
• Last Updated: January 16, 2025
• Results First Posted: April 21, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)