Status:
COMPLETED
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms, that is, state...
Detailed Description
Background Genetic polymorphisms in drug-metabolizing enzymes, transporters/receptors, and transcription factors might affect an individual s response to drug therapy. Inter-individual differences i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In this retrospective study, any cancer patients entered on IRB approved clinical trials at the National Cancer Institute are eligible. Studies for which pharmacokinetic analyses were/are being performed will be the source of the patient population. At this time enrollment will be limited to patients with pharmacokinetic samples obtained during treatment on protocol 00-C-0033, 00-C-0080, 01-C-0049, 01-C-0124, 01-C-0215, 02-C-0061, 02-C-0083, 02-C-0130, 02-C-0149, 02-C-0215, 02-C-0218, 02-C-0229, 03-C-0030, 03-C-0157, 03-C-0176, 03-C-0284, 04-C-0132, 04-C-0257, 04-C-0262, 04-C-0273, 04-C-0280, 05-C-0022, 05-C-0049, 05-C-0167, 05-C-0186, 06-C-0083, 06-C-0088, 06-C-0164, 06-C-0221, 07-C-0047, 07-C-0059, 07-C-0106, 07-C-0107, 08-C-0030, 08-C-0074, 94-C-0169, 95-C-0015, 97-C-0135, 97-C-0171, and 98-C-0015.
- EXCLUSION CRITERIA:
- A patient will be excluded if there is an insufficient quantity of sample available to perform the genotyping procedure. This is not anticipated to be of significance for this study since the methodology does not require a large serum sample.
Exclusion
Key Trial Info
Start Date :
September 7 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00341939
Start Date
September 7 2004
End Date
June 12 2024
Last Update
June 13 2024
Active Locations (1)
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1
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892