Trials / Completed
CompletedNCT03459729
Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer
PK Analysis of Antitumor B in Patients With Oral Cancer
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Medical College of Wisconsin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Study Intervention Description: Study participants will take the natural botanical compound ATB during a short window (7 to 28 days). Participants will provide blood samples, and saliva samples during Anti-tumor B (ATB) administration and a portion of the initial tumor biopsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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). |
Timeline
- Start date
- 2021-08-24
- Primary completion
- 2022-02-15
- Completion
- 2022-02-16
- First posted
- 2018-03-09
- Last updated
- 2025-01-16
- Results posted
- 2023-04-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03459729. Inclusion in this directory is not an endorsement.