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

NCT02722135 | Withdrawn Phase 1

• 2 other identifiers: 1230.282015-004625-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

Volasertib

EXPERIMENTAL

Drug: Volasertib

Interventions

Volasertib DRUG

Volasertib

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

BI 6727

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

BE (1)