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

January 26, 2017 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Volasertib
Drug: Volasertib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: up to 5 years
up to 5 years
Anti-leukaemic activity of volasertib in combination with standard salvage therapy
Time Frame: 8 weeks
8 weeks
Event-free survival (EFS)
Time Frame: up to 5 years
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
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
8 weeks
Predose concentration of volasertib before administration of second dose
Time Frame: 8 weeks
8 weeks
Area under the concentration-time curve of volasertib
Time Frame: 8 weeks
8 weeks
Terminal half-life of volasertib in plasma
Time Frame: 8 weeks
8 weeks
Maximum concentration of volasertib
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1230.28
  • 2015-004625-14 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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