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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00711594 |
The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine the recommended dose for the Phase II step. The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose determined in the Phase I step.
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, Efficacy Study |
Official Title: | Phase I/II Open Label Trial of Continuous Once Daily Oral Treatment With BIBW 2992 - Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib. |
Estimated Enrollment: | 72 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase II step;
Patients who have received the following pretreatments for the treatment of relapsed or metastatic NSCLC.
Exclusion Criteria:
Phase II step;
1) Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within two weeks before starting the study medication.
2) Radiotherapy within four weeks before enrolment. However, patients who have received definitive thoracic radiotherapy with curative intent should be excluded.
Patients who do not have sufficient baseline organ function and whose laboratory data do not meet the following criteria at the enrolment.
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Japan | |
1200.33.001 Boehringer Ingelheim Investigational Site | Recruiting |
Chuo-ku, Tokyo, Japan | |
1200.33.002 Boehringer Ingelheim Investigational Site | Recruiting |
Sunto-gun, Shizuoka, Japan | |
1200.33.007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Fukuoka, Fukuoka, Japan | |
1200.33.008 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Tokyo, Japan | |
1200.33.009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Okayama, Okayama, Japan | |
1200.33.010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Akashi, Hyogo, Japan | |
1200.33.011 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Kanazawa, Ishikawa, Japan | |
1200.33.012 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Sendaishi, Miyagi, Japan | |
1200.33.013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Hidaka-shi, Saitama, Japan | |
1200.33.006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Miyakojima-ku, Osaka, Japan | |
1200.33.015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Sapporo, Hokkaido, Japan | |
1200.33.016 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Niigata, Niigata, Japan | |
1200.33.017 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Nagoya, Aichi, Japan | |
1200.33.018 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Sakai-city, Osaka, Japan | |
1200.33.019 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Kobe, Hyogo, Japan | |
1200.33.003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Kashiwa, Chiba, Japan | |
1200.33.004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Nagoya, Aichi, Japan | |
1200.33.005 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Osaka-Sayama, Osaka, Japan | |
1200.33.014 Boehringer Ingelheim Investigational Site | Not yet recruiting |
Yufu, Oita, Japan |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1200.33 |
Study First Received: | July 8, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00711594 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Gefitinib 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 |