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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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10 December 2012 |
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Main ID: |
NCT01095926 |
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Date of registration:
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22/03/2010 |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of Doxorubicin in Children With Cancer
Doxo |
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Scientific title:
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Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01095926 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Germany
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Italy
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United Kingdom
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Contacts
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Name:
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Joachim Boos, MD, Prof. |
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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 Hospital Muenster |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients = 17 years of age
- plan to receive at least two cycles of doxorubicin
- must be enrolled in a national or European protocol for treatment of Wilms Tumours,
Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia
and must be treated with doxorubicin according to that protocol Or Patients < 3 years
enrolled or listed in any national or European study protocol for any paediatric
malignancy. Treatment with doxorubicin has to be according to that protocol.
- Parents or legal representative(s) must provide written informed consent to
participate in the trial according to national regulations. Patients that are able to
understand should provide assent to participate in the trial.
- Life expectancy of at least 3 month
- Karnofsky performance status of = 70%
- Additional blood withdrawal is acceptable for the patient. The decision is left to
the investigator
Exclusion Criteria:
- prior cardiac problems
Age minimum:
N/A
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Neuroblastoma
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Soft Tissue Sarcoma
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Wilms Tumor
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Intervention(s)
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Drug: doxorubicin
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Primary Outcome(s)
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Assess age-dependency in pharmacokinetics of doxorubicin in paediatric patients with solid tumours and leukaemia
[Time Frame: 24h]
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Secondary Outcome(s)
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Assess interindividual, intraindividual and residual variability of PK parameters in children
[Time Frame: 24h]
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Assess relationship between PK parameters and patient characteristics
[Time Frame: 24h]
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Evaluate the potential role of natriuretic peptides and troponin as indicators for subclinical cardiotoxicity
[Time Frame: 1 month]
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Explore in a preliminary fashion genetic polymorphisms that may influence doxorubicin clearance
[Time Frame: 5 years]
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Secondary ID(s)
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2009-011454-17
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EPOC-MS-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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