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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01023958 |
Purpose
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: BI 6727, IV infusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Single Arm Phase II Trial of Intravenous BI 6727 in 2nd Line Treatment of Urothelial Cancer |
| Enrollment: | 50 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: single arm
open label
|
Drug: BI 6727, IV infusion
phase II
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, California | |
| 1230.2.5 Boehringer Ingelheim Investigational Site | |
| Beverly Hills, California, United States | |
| 1230.2.10 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| United States, Florida | |
| 1230.2.34 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1230.2.29 Boehringer Ingelheim Investigational Site | |
| Orlando, Florida, United States | |
| United States, Illinois | |
| 1230.2.6 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| 1230.2.17 Boehringer Ingelheim Investigational Site | |
| Joliet, Illinois, United States | |
| United States, Louisiana | |
| 1230.2.24 Boehringer Ingelheim Investigational Site | |
| Metairie, Louisiana, United States | |
| United States, Maryland | |
| 1230.2.1 Boehringer Ingelheim Investigational Site | |
| Baltimore, Maryland, United States | |
| United States, Nevada | |
| 1230.2.25 Boehringer Ingelheim Investigational Site | |
| Las Vegas, Nevada, United States | |
| 1230.2.36 Boehringer Ingelheim Investigational Site | |
| Las Vegas, Nevada, United States | |
| United States, New Hampshire | |
| 1230.2.19 Boehringer Ingelheim Investigational Site | |
| Lebanon, New Hampshire, United States | |
| United States, New York | |
| 1230.2.23 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1230.2.20 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| 1230.2.12 Boehringer Ingelheim Investigational Site | |
| Charlotte, North Carolina, United States | |
| United States, Pennsylvania | |
| 1230.2.4 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| 1230.2.38 Boehringer Ingelheim Investigational Site | |
| Beaumont, Texas, United States | |
| 1230.2.41 Boehringer Ingelheim Investigational Site | |
| Tyler, Texas, United States | |
| 1230.2.43 Boehringer Ingelheim Investigational Site | |
| Webster, Texas, United States | |
| United States, Virginia | |
| 1230.2.44 Boehringer Ingelheim Investigational Site | |
| Fairfax, Virginia, United States | |
| Taiwan | |
| 1230.2.51 Boehringer Ingelheim Investigational Site | |
| Tainan, Taiwan | |
| 1230.2.50 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01023958 History of Changes |
| Other Study ID Numbers: | 1230.2 |
| Study First Received: | November 24, 2009 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Taiwan: Department of Health United States: Food and Drug Administration |
|
Neoplasms |