Spots Global Cancer Trial Database for BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
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Trial Identification
Brief Title: BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
Official 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 ID: NCT00701766
Conditions
Interventions
Study Description
Brief Summary: The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. Different schedules will be compared to identify the better dosing schedule for the further development programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for AML patients.
Detailed Description:
Keywords
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
1216.20.43001 Boehringer Ingelheim Investigational Site, Innsbruck, , Austria
1216.20.43002 Boehringer Ingelheim Investigational Site, Wien, , Austria
1216.20.49006 Boehringer Ingelheim Investigational Site, Bonn, , Germany
1216.20.49002 Boehringer Ingelheim Investigational Site, Frankfurt, , Germany
1216.20.49003 Boehringer Ingelheim Investigational Site, Freiburg, , Germany
1216.20.49004 Boehringer Ingelheim Investigational Site, Hannover-Heideviertel, , Germany
1216.20.49007 Boehringer Ingelheim Investigational Site, Heidelberg, , Germany
1216.20.49005 Boehringer Ingelheim Investigational Site, Münster, , Germany
1216.20.49001 Boehringer Ingelheim Investigational Site, Ulm, , Germany
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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