Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001696
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pharmacokinetic Study of Genistein a Tyrosine Kinase Inhibitor
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pharmacokinetic Study of Genistein a Tyrosine Kinase Inhibitor
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
Detailed Description:
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 ie 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 The duration of this study is estimated to be about 4 weeks long for each patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-C-0099 | None | None | None |