|
|
|
|
|
|
Sponsored by: |
Astellas Pharma Inc |
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00498914 |
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 |
MedlinePlus related topics: | Lymphoma |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects |
Estimated Enrollment: | 250 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: YM155
Continuous IV infusion
|
1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Astellas Pharma US Medical Information | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
Show 39 Study Locations |
Astellas Pharma Inc |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 155-CL-009, Eudra CT 2006-002584-70 |
First Received: | July 10, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00498914 |
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 |
|
|
|
|