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
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ClinicalTrials.gov Identifier: NCT02722135 |
Recruitment Status :
Withdrawn
First Posted : March 29, 2016
Last Update Posted : January 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Myeloid, Acute | Drug: Volasertib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label, Dose-escalating Trial to Evaluate the Tolerability, Toxicity, Safety, Pharmacokinetics, Pharmacodynamics and Activity of Volasertib Added to the Standard Intensive Salvage Chemotherapy Regimen With Liposomal Daunorubicine, Fludarabine and Cytarabine (DNX-FLA) Followed by Fludarabine and Cytarabine (FLA) in Children From 3 Months to Less Than 18 Years of Age With Acute Myeloid Leukaemia After Failure of the Front-line Therapy |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | September 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Volasertib |
Drug: Volasertib |
- 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 [ Time Frame: 4 weeks ]
- Anti-leukaemic activity of volasertib in combination with standard salvage therapy [ Time Frame: 8 weeks ]
- Event-free survival (EFS) [ Time Frame: up to 5 years ]
- Overall survival (OS) [ Time Frame: 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) [ Time Frame: 8 weeks ]
- Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. Adverse Events) [ Time Frame: 8 weeks ]
- Predose concentration of volasertib before administration of second dose [ Time Frame: 8 weeks ]
- Area under the concentration-time curve of volasertib [ Time Frame: 8 weeks ]
- Terminal half-life of volasertib in plasma [ Time Frame: 8 weeks ]
- Maximum concentration of volasertib [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 3 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients 3 months to <18 years of age at the time of informed consent
- Patients with AML after failure of the front-line intensive AML therapy
- Lansky score at screening >=50 for patients from 3 months to <12 years
- Karnofsky score at screening >=50 for patients from 12 to <18 years
- Use of highly effective methods of birth-control, if sexually active
- Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group
Exclusion criteria:
- Down syndrome
- Acute promyelocytic leukaemia and treatment-related AML
- QTc prolongation
- LVSF <30%
- Cardiac disease and/or dysfunction
- Active uncontrolled infection
- HIV infection, acute or chronic hepatitis
- Inadequate lab parameters
- Impaired renal function
- Pregnancy or nursing
- Further exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722135
Belgium | |
Boehringer Ingelheim Investigational Site | |
Gent, Belgium |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT02722135 |
Other Study ID Numbers: |
1230.28 2015-004625-14 ( EudraCT Number: EudraCT ) |
First Posted: | March 29, 2016 Key Record Dates |
Last Update Posted: | January 27, 2017 |
Last Verified: | January 2017 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |