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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00632749 |
The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, two schedules of BI 811283 in combination with LD-Ara-C will be investigated. In the phase I part, the dose of BI 811283 will be escalated to determine the maximum tolerated dose (MTD) of the two dosing schedules of BI 811283 in combination with LDAra-C. In the phase IIa part, the two combination schedules of BI 811283 at MTD with LD-Ara-C and one LD-Ara-C monotherapy schedule will be investigated to determine the efficacy of the two combination schedules in comparison to LD-Ara-C monotherapy in previously untreated AML patients ineligible for intensive treatment.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Acute |
Drug: BI 811283 Drug: Cytarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official 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 |
Estimated Enrollment: | 169 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Germany | |
1247.3.49001 Boehringer Ingelheim Investigational Site | Recruiting |
Ulm, Germany | |
1247.3.49002 Boehringer Ingelheim Investigational Site | Recruiting |
Münster, Germany | |
1247.3.49003 Boehringer Ingelheim Investigational Site | Recruiting |
Heidelberg, Germany | |
1247.3.49004 Boehringer Ingelheim Investigational Site | Recruiting |
Freiburg, Germany | |
1247.3.49009 Boehringer Ingelheim Investigational Site | Recruiting |
Fulda, Germany | |
1247.3.49007 Boehringer Ingelheim Investigational Site | Recruiting |
Berlin, Germany | |
1247.3.49008 Boehringer Ingelheim Investigational Site | Recruiting |
Bonn, Germany | |
1247.3.49006 Boehringer Ingelheim Investigational Site | Recruiting |
Hamburg, Germany | |
1247.3.49005 Boehringer Ingelheim Investigational Site | Recruiting |
Frankfurt/Main, Germany | |
1247.3.49010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Kiel, Germany | |
1247.3.49011 Boehringer Ingelheim Investigational Site | Not yet recruiting |
München, Germany | |
Spain | |
1247.3.3401 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Barcelona, Spain | |
1247.3.3402 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Badalona, Spain | |
1247.3.3404 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Valencia, Spain | |
1247.3.3410 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Santander, Spain | |
1247.3.3407 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Sevilla, Spain | |
1247.3.3408 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Cordoba, Spain | |
1247.3.3409 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Salamanca, Spain | |
1247.3.3405 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Valencia, Spain |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1247.3, EudraCT No.: 2007-005684-10 |
Study First Received: | March 4, 2008 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00632749 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte; Poland: Registration Medicinal Product Medical Device Biocidal Product; Romania: National Medicines Agency, Bucharest; Spain: Spanish Agency of Medicines |
Antimetabolites Anti-Infective Agents Leukemia Acute Myelocytic Leukemia Immunologic Factors |
Leukemia, Myeloid Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid |
Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Cytarabine |