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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00756223 |
The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
Condition | Intervention | Phase |
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Neoplasms |
Drug: BI 831266 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalation Trial in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 50 |
Study Start Date: | November 2008 |
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:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Austria | |
1257.1.4301 Boehringer Ingelheim Investigational Site | Recruiting |
Wien, Austria | |
1257.1.4302 Boehringer Ingelheim Investigational Site | Recruiting |
Salzburg, Austria | |
1257.1.4303 Boehringer Ingelheim Investigational Site | Recruiting |
Linz, Austria |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1257.1, EudraCT No.: 2008-001631-36 |
Study First Received: | September 19, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00756223 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Neoplasms |