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

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 1

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Volasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02722135

1230.28

2015-004625-14 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Volasertib

Experimental group

Treatment:

Drug: Volasertib