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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00748709 |
Purpose
The primary objective of this trial is to estimate the objective response rate for patients with tumors harbouring EGFR and/or HER2 gene amplifications or EGFR activating mutations who will be treated with BIBW 2992.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: BIBW 2992 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Label Phase II Trial of BIBW 2992 in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification or EFGR Activating Mutations. |
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
There are 2 Steps in the screening process:
Step 1 Inclusion criteria for pre-screening:
Step 2 Inclusion criteria for enrollment:
Patients who have tested positive for FISH and are considered candidate for this trial must meet all of the following inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| United States, Colorado | |
| 1200.26.11 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Denver, Colorado, United States | |
| United States, Florida | |
| 1200.26.5 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Ocoee, Florida, United States | |
| United States, Georgia | |
| 1200.26.16 Boehringer Ingelheim Investigational Site | Withdrawn |
| Augusta, Georgia, United States | |
| United States, Indiana | |
| 1200.26.9 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Indianapolis, Indiana, United States | |
| United States, Massachusetts | |
| 1200.26.1 Boehringer Ingelheim Investigational Site | Recruiting |
| Boston, Massachusetts, United States | |
| United States, Nevada | |
| 1200.26.13 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| 1200.26.2 Boehringer Ingelheim Investigational Site | Recruiting |
| New York, New York, United States | |
| 1200.26.4 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Albany, New York, United States | |
| United States, Ohio | |
| 1200.26.7 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Kettering, Ohio, United States | |
| United States, Oregon | |
| 1200.26.14 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Springfield, Oregon, United States | |
| United States, Texas | |
| 1200.26.12 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Dallas, Texas, United States | |
| 1200.26.15 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Austin, Texas, United States | |
| 1200.26.8 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Tyler, Texas, United States | |
| United States, Virginia | |
| 1200.26.6 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| 1200.26.10 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vancouver, Washington, United States | |
| Taiwan | |
| 1200.26.88603 Boehringer Ingelheim Investigational Site | Recruiting |
| Tainan, Taiwan | |
| 1200.26.88601 Boehringer Ingelheim Investigational Site | Recruiting |
| Taipei, Taiwan | |
| 1200.26.88602 Boehringer Ingelheim Investigational Site | Recruiting |
| Tao-Yuan, Taiwan | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1200.26 |
| Study First Received: | September 8, 2008 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00748709 History of Changes |
| Health Authority: | Taiwan: Department of Health; United States: Food and Drug Administration |
|
Neoplasms |