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NCT00001696 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Genistein, a Tyrosine Kinase Inhibitor
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00001696: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001696 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001696, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Genistein is a natural product found in soy beans; its consumption has been associated with a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases in cell adhesion in vivo would phenotypically reverse the first step in the metastatic cascade, potentially preventing metastasis formation, and is consistent with epidemiologic findings. This study seeks to determine the pharmacokinetics of genistein in humans by administering a single dose of genistein and performing a pharmacokinetic analysis. Patients will be treated with two formulations of genistein (a 43% genistein preparation or a 90% preparation). This is a phase I study, and patients will be treated on one of three dosing levels. Patients will be randomly assigned to receive one formulation first, followed by a washout period, and will then receive the second preparation (i.e. a randomized cross over design). Information from this study will be used to optimally design a multiple dose study wherein patients will be treated for longer periods of time.
Interventions
- DRUG Genistein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1998-04 |
| Est. Completion | 2001-03 |
| Phase | Phase 1 |
What the finished NCT00001696 record still lists
NCT00001696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Genistein is the first listed.
NCT00001696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001696 about?
NCT00001696 is a clinical study titled "A Pharmacokinetic Study of Genistein, a Tyrosine Kinase Inhibitor". Genistein is a natural product found in soy beans; its consumption has been associated with a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases in cell adhesion in viv...
What is the current status of trial NCT00001696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1998-04. Estimated completion is 2001-03.
What interventions are being tested in trial NCT00001696?
The interventions under investigation include: Genistein (DRUG).
Who is sponsoring clinical trial NCT00001696?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001696's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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