Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known

• Status: Completed
• Trial end date: 2017-01-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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