EUCTR2009-011454-17-DEActive, not recruitingNot Applicable
Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia - Doxo
niversitätsklinikum Münster0 sites100 target enrollmentStarted: November 17, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
- •- Patient, 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- prior cardiac problems
Investigators
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