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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00875433 |
A phase II trial to assess the impact of BIBW 2992 on the heart (QTcF) and the effectiveness of BIBW 2992 in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
Condition | Intervention | Phase |
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Neoplasms |
Drug: BIBW 2992 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Open Label Trial to Assess the Efficacy and the Imapct on QTcF of Continuous Oral BIBW 2992 at a Daily Dose of 50mg in Patients With Relapsed or Refractory Solid Tumours Including Patients With Brain Metastases and Those With Glioblastoma Not Amenable to Other Therapy |
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | May 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:
For patients with Glioma and brain metastases the following additional inclusion criteria should apply:
Exclusion Criteria:
Major exclusion criteria;
For Patients with glioma and brain metastases additional exclusion criteria apply;
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
United Kingdom | |
1200.24.4401 Boehringer Ingelheim Investigational Site | Recruiting |
Sutton, United Kingdom | |
1200.24.4402 Boehringer Ingelheim Investigational Site | Recruiting |
London, United Kingdom | |
1200.24.4403 Boehringer Ingelheim Investigational Site | Recruiting |
Guildford, United Kingdom | |
1200.24.4404 Boehringer Ingelheim Investigational Site | Not yet recruiting |
London, United Kingdom |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1200.24 |
Study First Received: | April 2, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00875433 History of Changes |
Health Authority: | Great Britain: MHRA; United States: Food and Drug Administration |
Glioblastoma Neoplasm Metastasis |
Neoplasms |