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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: |
NCT00897871 |
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Date of registration:
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09/05/2009 |
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Primary sponsor: |
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Public title:
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Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer
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Scientific title:
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Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00897871 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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Ireland
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United Kingdom
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Contacts
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Name:
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Gareth Veal |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Newcastle Upon-Tyne |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of childhood cancer
- Receiving carboplatin, cyclophosphamide, or etoposide as standard treatment as part
of a clinical study at a Children's Cancer and Leukemia Group (CCLG) center
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Single or double lumen central venous catheter in place
- No concurrent anticonvulsants, azole antifungal agents, or chronic steroid treatment
Age minimum:
N/A
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unspecified Childhood Solid Tumor, Protocol Specific
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Intervention(s)
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Drug: carboplatin
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Drug: cyclophosphamide
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Drug: etoposide phosphate
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Genetic: gene expression analysis
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Genetic: polymorphism analysis
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Other: pharmacological study
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Primary Outcome(s)
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Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival
[Time Frame: No]
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Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity
[Time Frame: No]
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Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites
[Time Frame: No]
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Pharmacokinetic parameters
[Time Frame: No]
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Secondary ID(s)
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CCLG-PK-2006-09
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CDR0000560121
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EU-20742
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EUDRACT-2006-002845-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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