NCT03459729

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

Completed EARLY_PHASE1 Results posted Last updated 16 January 2025

What this trial tests

EARLY_PHASE1 trial testing Antitumor B in Squamous Cell Carcinoma of the Oral Cavity in 6 participants. Completed in 16 February 2022.

Timeline

24 August 2021

Primary endpoint
15 February 2022

16 February 2022

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	6
Start date	24 August 2021
Primary completion	15 February 2022
Estimated completion	16 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Antitumor B — full drug profile →

Conditions studied

• Squamous Cell Carcinoma of the Oral Cavity — all drugs for Squamous Cell Carcinoma of the Oral Cavity →

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Squamous Cell Carcinoma of the Oral Cavity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Curve (AUC) for Matrine in Saliva Primary · Day 1

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.

Group	Value	95% CI
Antitumor B	4007.9	± 2882.9

Area Under the Curve for Matrine in Plasma Primary · Day 1

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.

Group	Value	95% CI
Antitumor B	783.2	± 283.7

Maximum Concentration (Cmax) of Matrine in Saliva Primary · Day 1

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

Group	Value	95% CI
Antitumor B	457.4	± 380.3

Maximum Concentration of Matrine in Plasma Primary · Day 1

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

Group	Value	95% CI
Antitumor B	54.5	± 14.7

Area Under the Curve (AUC) for Maackiain in Saliva Primary · Day 1

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.

Group	Value	95% CI
Antitumor B	0.6	± 0.4

Area Under the Curve (AUC) for Maackiain in Plasma Primary · Day 1

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.

Group	Value	95% CI
Antitumor B	4.4	± 3.2

Maximum Concentration of Maackiain in Saliva Primary · Day 1

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

Group	Value	95% CI
Antitumor B	0.2	± 0.1

Maximum Concentration of Maackiain in Plasma Primary · Day 1

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

Group	Value	95% CI
Antitumor B	0.3	± 0.2

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comprehending the crosstalk between Notch, Wnt and Hedgehog signaling pathways in oral squamous cell carcinoma - clinical implications.
   Patni AP, Harishankar MK, Joseph JP, Sreeshma B, et al · · 2021 · cited 38× · PMID 33704672 · DOI 10.1007/s13402-021-00591-3
2. Pharmacokinetic Characterization and Bioavailability Barrier for the Key Active Components of Botanical Drug Antitumor B (ATB) in Mice for Chemoprevention of Oral Cancer.
   Bui D, Yin T, Duan S, Wei B, et al · · 2021 · cited 4× · PMID 34463097 · DOI 10.1021/acs.jnatprod.1c00501
3. Pharmacokinetic Basis for Using Saliva Matrine Concentrations as a Clinical Compliance Monitoring in Antitumor B Chemoprevention Trials in Humans.
   Bui D, McWilliams LA, Wu L, Zhou H, et al · · 2022 · cited 3× · PMID 36612086 · DOI 10.3390/cancers15010089