Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
Status and phase
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Study type
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Details and patient eligibility
About
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients
Enrollment
Sex
Ages
Volunteers
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
Exclusion criteria
- patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy
- presence of cardiac disease (LVEF by echocardiography less than 25 %)
- symptomatic Central Nervous System 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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