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NCT03459729 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer
A Early Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03459729: Completed Early Phase 1 study, sponsored by Medical College of Wisconsin.
NCT03459729 is a Early Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459729, a Early Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Antitumor B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2022-02-16 |
| Phase | Early Phase 1 |
What the finished NCT03459729 record still lists
NCT03459729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Antitumor B is the first listed.
NCT03459729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459729 about?
NCT03459729 is a clinical study titled "Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer". 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 eff...
What is the current status of trial NCT03459729?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2021-08-24. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT03459729?
The interventions under investigation include: Antitumor B (DRUG).
Who is sponsoring clinical trial NCT03459729?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459729's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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