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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00498914 |
Purpose
A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Large-Cell, Diffuse Lymphoma, B-Cell Refractory |
Drug: YM155 |
Phase II |
| 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: | A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects |
| Enrollment: | 41 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: YM155
Continuous IV infusion
|
1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155
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 | |
| Beverly Hills, California, United States, 90211 | |
| Palo Alto, California, United States, 94305 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Missouri | |
| St Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| Houston, Texas, United States, 77303 | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Ontario | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| France | |
| Bordeaux, France, 33076 | |
| Montpellier, France, 34295 | |
| Nantes, France, 44093 | |
| Nice, France, 06200 | |
| Poitiers, France, 86021 | |
| Rouen, France, 76038 | |
| Tours, France, 37044 | |
| Spain | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28041 | |
| Study Director: | Use Central Contact | Astellas Pharma Global Development |
More Information
| Responsible Party: | Sr Manager Clinical Trial Registry, Astellas Pharma Global Development |
| ClinicalTrials.gov Identifier: | NCT00498914 History of Changes |
| Other Study ID Numbers: | 155-CL-009, Eudra CT 2006-002584-70 |
| Study First Received: | July 10, 2007 |
| Last Updated: | May 8, 2009 |
| Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada |
|
Lymphoma, Large-Cell, Diffuse Lymphoma, B-Cell YM155 Treatment outcomes Refractory |
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |