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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00730925 |
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: BIBW 2992 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Single-Arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | April 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 |
Belgium | |
1200.41.32001 Boehringer Ingelheim Investigational Site | Recruiting |
Jette, Belgium | |
1200.41.32003 Boehringer Ingelheim Investigational Site | Recruiting |
Antwerpen, Belgium | |
1200.41.32006 Boehringer Ingelheim Investigational Site | Recruiting |
Namur, Belgium | |
1200.41.32010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Luxembourg, Belgium | |
1200.41.32008 Boehringer Ingelheim Investigational Site | Recruiting |
Liège, Belgium | |
1200.41.32009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Brasschaat, Belgium | |
1200.41.32007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Charleroi, Belgium |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1200.41 |
Study First Received: | June 30, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00730925 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |