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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00727506 |
Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV).
Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.
Condition | Intervention | Phase |
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Glioma |
Drug: BIBW 2992 Drug: TMZ |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of BIBW 2992 in Treating Patients With Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 140 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 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:
Phase I Part:
Phase II part only:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
United States, Alabama | |
1200.36.0016 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Birmingham, Alabama, United States | |
United States, Arizona | |
1200.36.0012 Boehringer Ingelheim Investigational Site | Recruiting |
Phoenix, Arizona, United States | |
United States, California | |
1200.36.0005 Boehringer Ingelheim Investigational Site | Recruiting |
Duarte, California, United States | |
1200.36.0014 Boehringer Ingelheim Investigational Site | Recruiting |
Los Angeles, California, United States | |
United States, Colorado | |
1200.36.0013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Aurora, Colorado, United States | |
United States, Indiana | |
1200.36.0015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Indianapolis, Indiana, United States | |
United States, Kentucky | |
1200.36.0008 Boehringer Ingelheim Investigational Site | Recruiting |
Louisville, Kentucky, United States | |
United States, Massachusetts | |
1200.36.0002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Boston, Massachusetts, United States | |
United States, Michigan | |
1200.36.0003 Boehringer Ingelheim Investigational Site | Recruiting |
Detroit, Michigan, United States | |
United States, New Hampshire | |
1200.36.0004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Lebanon, New Hampshire, United States | |
United States, New York | |
1200.36.0009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
New York, New York, United States | |
1200.36.0018 Boehringer Ingelheim Investigational Site | Not yet recruiting |
New York, New York, United States | |
United States, North Carolina | |
1200.36.0001 Boehringer Ingelheim Investigational Site | Recruiting |
Durham, North Carolina, United States | |
United States, South Carolina | |
1200.36.0007 Boehringer Ingelheim Investigational Site | Recruiting |
Charleston, South Carolina, United States | |
United States, Texas | |
1200.36.0017 Boehringer Ingelheim Investigational Site | Recruiting |
Dallas, Texas, United States | |
1200.36.0010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Houston, Texas, United States | |
United States, Virginia | |
1200.36.0011 Boehringer Ingelheim Investigational Site | Recruiting |
Charlotteville, Virginia, United States |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1200.36 |
Study First Received: | July 31, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00727506 |
Health Authority: | Canada: Health Canada, The Health Products and Food Branch; United States: Food and Drug Administration |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Temozolomide Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |