EUCTR2013-001291-38-BEActive, not recruitingPhase 1
Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known - Determination of MTD of volasertib in paediatric patients with advanced cancer
SCS Boehringer Ingelheim Comm.V0 sites60 target enrollmentStarted: October 23, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known
- •- Lansky score > 60 for children 2 to less than 12 years
- •- Karnofsky score > 60 for children aged 12 or older
- •- life expectancy of at least 6 weeks as judged by the investigator
- •-parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
- •- patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy
- •- presence of cardiac disease (left ventricular shortening fraction by echocardiography < 30 %)
- •- symptomatic CNS involvement of the malignant disease
- •- primary CNS tumour
- •- inadequate lab parameters
- •- inadequate venous access
- •- QTc prolongation
- •- pregnancy, breastfeeding
- •- other diseases or CTs that might interfere with evaluation of safety
Investigators
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