Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341939
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2006-06-19
Brief Title:
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Retrospective Analysis of Drug Disposition and Response-related Genotypes in Cancer Patients and Correlation With Pharmacokinetics and Pharmacodynamics Data
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This study is a retrospective one exploring the hypothesis that a persons genotypic makeup may be associated with a clinical response or toxic effect to a drug Genetic polymorphisms that is states of being able to assume different forms that are in drug-metabolizing enzymes transporters and receptors may affect a patients response to drug therapy To date there have been limited studies looking at a drug-metabolizing genotype genetic makeup or phenotype result of the genotypes interaction with the environment However it is often wondered if the variations in a drugs action that is pharmacokinetic effect come from the genotype phenotype relationship
Participants who entered previous clinical trials at the National Cancer Institute as approved by the Central Institutional Review Board may be eligible for this study Studies for which pharmacokinetic analyses were or are being performed will be the source of the patient population
Genotyping experiments will be performed through genomic DNA isolated from stored frozen serum The genotyping results will be compared with pharmacokinetic data and clinical outcomes Clinical data will consist of what is obtained during the course of the principal pharmacokinetic study The results of the retrospective analyses will provide no direct benefit to the participants
Participants who entered previous clinical trials at the National Cancer Institute as approved by the Central Institutional Review Board may be eligible for this study Studies for which pharmacokinetic analyses were or are being performed will be the source of the patient population
Genotyping experiments will be performed through genomic DNA isolated from stored frozen serum The genotyping results will be compared with pharmacokinetic data and clinical outcomes Clinical data will consist of what is obtained during the course of the principal pharmacokinetic study The results of the retrospective analyses will provide no direct benefit to the participants
Detailed Description:
Background
Genetic polymorphisms in drug-metabolizing enzymes transportersreceptors and transcription factors might affect an individual s response to drug therapy
Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially important given the narrow therapeutic index of these drugs
During analysis of investigational agents inter-individual variances in pharmacokinetics and pharmacodynamics are often noted It is often wondered if these variances might in part be explained by genetic differences in drug metabolizing enzymes transporters or other critical regulators of gene expression
Objectives
To better understand the genotype-phenotype relationship additional analysis correlating pharmacokinetic data with relevant genotyping
Eligibility
All individuals previously enrolled on IRB approved clinical trials at the National Cancer Institute
Design
In these retrospective studies the association between an individual s pharmacokinetic profile and the genetic variation in their drug metabolizing enzymes and other critical regulators of gene expression will be investigated
The hypothesis that an individual s genotypic constitution may be associated with clinical response andor toxicity will be explored
Genetic polymorphisms in drug-metabolizing enzymes transportersreceptors and transcription factors might affect an individual s response to drug therapy
Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially important given the narrow therapeutic index of these drugs
During analysis of investigational agents inter-individual variances in pharmacokinetics and pharmacodynamics are often noted It is often wondered if these variances might in part be explained by genetic differences in drug metabolizing enzymes transporters or other critical regulators of gene expression
Objectives
To better understand the genotype-phenotype relationship additional analysis correlating pharmacokinetic data with relevant genotyping
Eligibility
All individuals previously enrolled on IRB approved clinical trials at the National Cancer Institute
Design
In these retrospective studies the association between an individual s pharmacokinetic profile and the genetic variation in their drug metabolizing enzymes and other critical regulators of gene expression will be investigated
The hypothesis that an individual s genotypic constitution may be associated with clinical response andor toxicity will be explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 04-C-N279 | None | None | None |