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

NCT ID: NCT02722135

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-09-30

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volasertib

Group Type: EXPERIMENTAL

Volasertib

Intervention Type: DRUG

Interventions

Volasertib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2015-004625-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1230.28

Identifier Type: -

Identifier Source: org_study_id