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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00716417 |
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU. The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
Condition | Intervention | Phase |
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Neoplasms |
Drug: BIBW 2992 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase Ib Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Continuous Dosing With BIBW 2992 Combined With Two Different Regimens of Backbone Chemotherapy: Cisplatin Combined With 5 Fluorouracil and Cisplatin Combined With Paclitaxel in Patients With Advanced Solid Tumors. |
Estimated Enrollment: | 42 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | December 2009 (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 | |
1200.37.3202 Boehringer Ingelheim Investigational Site | Recruiting |
Bruxelles, Belgium | |
1200.37.3203 Boehringer Ingelheim Investigational Site | Recruiting |
Gent, Belgium | |
1200.37.3201 Boehringer Ingelheim Investigational Site | Recruiting |
Edegem, Belgium |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1200.37, EUDRACT2008 002613 43 |
Study First Received: | July 15, 2008 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00716417 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products |
Radiation-Sensitizing Agents Cisplatin Paclitaxel Fluorouracil |
Neoplasms Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |