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. [intravenous] 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.

Trial Profile

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. [intravenous] 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.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2014

At a glance

  • Drugs BI 2536 (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 06 Jun 2012 New source identified and integrated (German Clinical Trials Register DRKS00003838).
    • 12 Jul 2011 New source identified and integrated (European Clinical Trials Database record, EudraCT2006-000613-38).
    • 04 Dec 2009 Actual patient number (70) added as reported by ClinicalTrials.gov.
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