Value through Innovation27 July 2016

Clinical Study Results

  • BI 2536 - Leukemia, Myeloid, Acute
    Clinical Study Number 1216.20
    Study Indication Leukemia, Myeloid, Acute
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on Day 1 in comparison to single doses i.v. BI 2536 on Days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia

    Study Document Trial synopsis 1216.20_CO english
  • BI 811283 - Leukemia, Myeloid, Acute
    Clinical Study Number 1247.3
    Study Indication Leukemia, Myeloid, Acute
    Product BI 811283
    Generic Name BI 811283
    Lab Code
    Clinical Phase I
    Study Title

    An open Phase I/IIa trial to investigate the maximum tolerated dose, safety, efficacy and pharmacokinetics of BI 811283 in combination with cytarabine in patients with previously untreated acute myeloid leukaemia ineligible for intensive treatment

    Study Document Trial synopsis 1247.3 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.30
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, Phase I, dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of volasertib in combination with decitabine in patients >= 65 years with acute myeloid leukemia

    Study Document Trial statement 1230.30 english Trial synopsis 1230.30 english Lay summary 1230.30 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.26
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, phase I trial of intravenous once every 2 weeks administration of BI 6727 in Japanese patients with acute myeloid leukemia

    Study Document Trial synopsis 1230.26 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.25
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II/III
    Study 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 treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

    Study Document Trial statement 1230.25 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.28
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study 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 Document Trial statement 1230.28 english

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