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Clinical trials for Volasertib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Volasertib. Displaying page 1 of 1.
    EudraCT Number: 2015-004625-14 Sponsor Protocol Number: 1230.28 Start Date*: 2016-07-05
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full 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 ...
    Medical condition: Paediatric AML after first-line failure
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) DK (Prematurely Ended) CZ (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002487-27 Sponsor Protocol Number: 1230.14 Start Date*: 2013-01-21
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥...
    Medical condition: previously untreated acute myeloid leukaemia in patients ≥ 65 years and ineligible for intensive remission induction therapy
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PT (Completed) GR (Completed) AT (Completed) FI (Completed) ES (Completed) IT (Completed) CZ (Completed) NL (Completed) HU (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-000477-39 Sponsor Protocol Number: AMLSG20-13 Start Date*: 2016-01-29
    Sponsor Name:University Hospital Ulm
    Full Title: Dose Finding safety run in Phase followed by a randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) Administered Prior or After Chemotherapy in Patients With New...
    Medical condition: patients with newly diagnosed high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10068361 MDS LLT
    18.1 100000004864 10001941 AML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001291-38 Sponsor Protocol Number: 1230.27 Start Date*: 2013-09-23
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co.KG
    Full Title: Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability and toxicity of volasertib in paediatric patients from 2 years to less than 18 y...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10048683 Advanced cancer LLT
    17.1 10005329 - Blood and lymphatic system disorders 10024324 Leukaemias HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) AT (Completed) SK (Completed) BE (Completed) NL (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-023499-25 Sponsor Protocol Number: 1230.25 Start Date*: 2011-06-16
    Sponsor Name: [...]
    1.
    2. Boehringer Ingelheim AB
    Full Title: A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator’s choice of anti-leukemic t...
    Medical condition: Relapsed or refractory acute myeloid leukemia in adult patients who are considered not to benefit from / not to be eligible for intensive salvage therapy and/or stem cell transplantation and have n...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066638 Acute myeloid leukemia progression LLT
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060558 Acute myeloid leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended) AT (Prematurely Ended) NL (Completed) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-003617-27 Sponsor Protocol Number: 1230.4 Start Date*: 2008-11-07
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open phase I/IIa trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of intraveneous BI 6727 as monotherapy or in combination with subcutaneous cytarabine in...
    Medical condition: patients with acute myeloid leukaemia (AML) that are not eligible for intensive treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015770-35 Sponsor Protocol Number: 1230.18 Start Date*: 2010-03-17
    Sponsor Name:Boehringer Ingelheim France
    Full Title: Phase II randomized trial of the Polo-like kinase 1 inhibitor BI 6727 monotherapy versus investigator’s choice chemotherapy in ovarian cancer patients resistant or refractory to platinum-based cyto...
    Medical condition: Recurrent ovarian cancer resistant or refractory to platinum compounds
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) ES (Completed) BE (Completed) SE (Completed) SK (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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