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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00701766 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Acute |
Drug: BI 2536 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 84 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Austria | |
1216.20.43001 Boehringer Ingelheim Investigational Site | Recruiting |
Innsbruck, Austria | |
1216.20.43002 Boehringer Ingelheim Investigational Site | Recruiting |
Wien, Austria | |
Germany | |
1216.20.49001 Boehringer Ingelheim Investigational Site | Recruiting |
Ulm, Germany | |
1216.20.49002 Boehringer Ingelheim Investigational Site | Recruiting |
Frankfurt, Germany | |
1216.20.49007 Boehringer Ingelheim Investigational Site | Recruiting |
Heidelberg, Germany | |
1216.20.49004 Boehringer Ingelheim Investigational Site | Active, not recruiting |
Hannover-Heideviertel, Germany | |
1216.20.49005 Boehringer Ingelheim Investigational Site | Completed |
Münster, Germany | |
1216.20.49006 Boehringer Ingelheim Investigational Site | Recruiting |
Bonn, Germany | |
1216.20.49003 Boehringer Ingelheim Investigational Site | Recruiting |
Freiburg, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1216.20, EudraCT No:2006-000613-38 |
Study First Received: | June 18, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00701766 |
Health Authority: | Austria: Federal Office for Safety in Health Care; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |