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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00838370 |
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Date of registration:
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05/02/2009 |
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Primary sponsor: |
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Public title:
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Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
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Scientific title:
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Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00838370 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jan HM Schellens, MD, PhD |
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Address:
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Telephone:
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0031205122446 |
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Email:
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j.slijkerman@nki.nl |
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Affiliation:
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Name:
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Jan HM Schellens, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Netherlands Cancer Institute, Amsterdam, the Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histological proof of cancer
- patient is considered for treatment with capecitabine or 5-FU
- hetero- or homozygous mutant for DPYD*2A
- able and willing to give written informed consent
- able and willing to undergo blood sampling for pharmacokinetic analysis
- life expectancy 3 months or longer
- acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine,
- WHO performance status 0-2
- no radio- or chemotherapy within the last 3 weeks prior to study entry
Exclusion Criteria:
- patients with known alcoholism, drug addiction and/or psychotic disorders that are
not suitable for adequate follow-up
- women who are pregnant or breast-feeding
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Intervention(s)
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Drug: Capecitabine, 5-fluorouracil
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Primary Outcome(s)
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safety
[Time Frame: during fluoropyrimidine treatment of the patient]
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Secondary Outcome(s)
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cost-effectiveness
[Time Frame: during fluoropyrimidine treatment of the patient]
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Secondary ID(s)
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NKI-AVL_M07PFU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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