Open dose escalating trial to determine the maximum tolerated dose in paediatric patients with advanced leukaemia or solid tumours

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001291-38-CZ

Enrollment

Registered

2013-09-12

Start date

2013-12-09

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 17.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 100000004864 MedDRA version: 17.0 Level: HLGT Classification code 10024324 Term: Leukaemias System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Volasertib Product Code: BI 6727 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Volasertib Current Sponsor code: BI 6727 Concentration unit: mg/ml milligram(s)/millilitr

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: determination of MTD of volasertib in paediatric patients with cancer;Secondary Objective: safety, preliminary efficacy, pharmacokinetics in a paediatric patient population;Primary end point(s): 1: number of patients with dose limiting toxicity ;Timepoint(s) of evaluation of this end point: 1: 14 days	—

Secondary

Measure	Time frame
Secondary end point(s): 1: number of patients with hepatic injury as defined as protocol-specified adverse events of special interest 2: number of patients with clinically relevant lab value changes of calcium (hyper and/or hypocalcaemia) as judged by the investigator and reported as adverse events (Common Terminology Criteria for Adverse Eevent grade 3 or higher) 3: number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations ( Adverse Events) 4: number of patients with complete remission (CR) 5: progression free survival 6: overall survival 7: pharmacokinetics 8: number of patients with complete remission with incomplete blood count (CRi) 9: number of patients with partial response/remission (PR) ;Timepoint(s) of evaluation of this end point: 1: up to 6 months 2: up to 6 months 3: up to 6 months 4: up to 6 months 5: up to one year 6: up to one year 7: up to six months 8: up to 6 months 9: up to 6 months	—

Measure

Time frame

Secondary end point(s): 1: number of patients with hepatic injury as defined as protocol-specified adverse events of special interest 2: number of patients with clinically relevant lab value changes of calcium (hyper and/or hypocalcaemia) as judged by the investigator and reported as adverse events (Common Terminology Criteria for Adverse Eevent grade 3 or higher) 3: number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations ( Adverse Events) 4: number of patients with complete remission (CR) 5: progression free survival 6: overall survival 7: pharmacokinetics 8: number of patients with complete remission with incomplete blood count (CRi) 9: number of patients with partial response/remission (PR) ;Timepoint(s) of evaluation of this end point: 1: up to 6 months 2: up to 6 months 3: up to 6 months 4: up to 6 months 5: up to one year 6: up to one year 7: up to six months 8: up to 6 months 9: up to 6 months

—

Countries

Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Slovakia, United Kingdom

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com498002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026