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Trial Outcomes & Findings for Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer (NCT NCT03459729)

NCT ID: NCT03459729

Last Updated: 2025-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

6 participants

Primary outcome timeframe

Day 1

Results posted on

2025-01-16

Participant Flow

Six prospective subjects signed the Institutional Review Board-approved consent form. Two subjects did not meet eligibility criteria during screening and were excluded.

Participant milestones

Participant milestones
Measure
Antitumor B
Antitumor B (ATB) will be administered on an outpatient basis. 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).
Overall Study
STARTED
6
Overall Study
Received Therapy
4
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Antitumor B
Antitumor B (ATB) will be administered on an outpatient basis. 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).
Overall Study
Physician Decision
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
Age, Continuous
67.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Area Under the Curve (AUC) for Matrine in Saliva
4007.9 ng x h/mL
Standard Deviation 2882.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Area Under the Curve for Matrine in Plasma
783.2 ng x h/mL
Standard Deviation 283.7

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Maximum Concentration (Cmax) of Matrine in Saliva
457.4 ng/mL
Standard Deviation 380.3

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Maximum Concentration of Matrine in Plasma
54.5 ng/mL
Standard Deviation 14.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Area Under the Curve (AUC) for Maackiain in Saliva
0.6 ng x h/mL
Standard Deviation 0.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Area Under the Curve (AUC) for Maackiain in Plasma
4.4 ng x h/mL
Standard Deviation 3.2

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Maximum Concentration of Maackiain in Saliva
0.2 ng/mL
Standard Deviation 0.1

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure
Antitumor B
n=4 Participants
ATB will be administered on an outpatient basis. 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).
Maximum Concentration of Maackiain in Plasma
0.3 ng/mL
Standard Deviation 0.2

Adverse Events

Antitumor B

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stuart Wong, MD

Froedtert and the Medical college of Wisconsin

Phone: 414-805-4600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place