A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
This study is currently recruiting participants.
Verified May 2013 by Eisai Inc.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: August 30, 2012
Last updated: May 30, 2013
Last verified: May 2013
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
Hypervascular Tumor and Arteriovenous Malformation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation|
Resource links provided by NLM:
Genetics Home Reference related topics: capillary malformation-arteriovenous malformation syndrome Parkes Weber syndromeU.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- To evaluate the efficacy of study device with E7040, success rate of embolization in the target vessel and operability of transcatheter arterial embolization [ Time Frame: up to 12 weeks after the treatment start ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
E7040 of optimal particle size (-300 μm, 300-500 μm, or 500-700 μm to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677624
|Contact: Department of Customer Joy EJ||_ML_CLNCL@hhc.eisai.co.jp|
|Hirosaki, Aomori, Japan|
|Futsukaichi, Fukuoka, Japan|
|Kurume, Fukuoka, Japan|
|Nishinomiya, Hyogo, Japan|
|Kanazawa, Ishikawa, Japan|
|Tsu, Mie, Japan|
|Chuo-ku, Tokyo, Japan|
|Minato-ku, Tokyo, Japan|
Sponsors and Collaborators
Eisai Co., Ltd.
|Study Director:||Shin Maeda||Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems|