A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed

Phase 1

Withdrawn

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: Volasertib

• Registration Number: NCT02722135
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-29
• Study Start: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27
• Primary Completion: 2018-05
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volasertib	Volasertib	-

Primary Outcome Measures

Name	Time	Method
Determination of the maximal tolerated dose of volasertib or the recommended volasertib dose for further studies in combination with standard salvage therapy in paediatric patients with AML after failure of the front-line intensive chemotherapy regimen	4 weeks

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of volasertib	8 weeks
Terminal half-life of volasertib in plasma	8 weeks
Maximum concentration of volasertib	8 weeks
Anti-leukaemic activity of volasertib in combination with standard salvage therapy	8 weeks
Event-free survival (EFS)	up to 5 years
Overall survival (OS)	up to 5 years
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 Events (CTCAE) grade 3 or higher)	8 weeks
Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. Adverse Events)	8 weeks
Predose concentration of volasertib before administration of second dose	8 weeks

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium