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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Volasertib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Volasertib Drug: Volasertib


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Anti-leukaemic activity of volasertib in combination with standard salvage therapy [ Time Frame: 8 weeks ]
  2. Event-free survival (EFS) [ Time Frame: up to 5 years ]
  3. Overall survival (OS) [ Time Frame: up to 5 years ]
  4. 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 ]
  5. Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. Adverse Events) [ Time Frame: 8 weeks ]
  6. Predose concentration of volasertib before administration of second dose [ Time Frame: 8 weeks ]
  7. Area under the concentration-time curve of volasertib [ Time Frame: 8 weeks ]
  8. Terminal half-life of volasertib in plasma [ Time Frame: 8 weeks ]
  9. Maximum concentration of volasertib [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Further exclusion criteria apply
Contacts and Locations
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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


Locations
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Belgium
Boehringer Ingelheim Investigational Site
Gent, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02722135     History of Changes
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
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms