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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00633100 |
The purpose of this study is to determine the efficacy, safety and the duration of response in patients with advanced or relapsed breast cancer by intravenously administering E7389.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: E7389 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Clinical Study of E7389 for Advanced or Relapsed Breast Cancer |
Estimated Enrollment: | 82 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: E7389
One cycle consists of 3 weeks. E7389 will be administered for 2 cycles or more in principle. Administration can be continued as long as the subject does not meet the discontinuation criteria.
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E7389 will be intravenously administered on Days 1 and 8 of a 21 day cycle.
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with serious complications:
Contact: Customer Information Services Department CRC and QA | _ML_CLNCL@hhc.eisai.co.jp |
Japan | |
Recruiting | |
Fukuoka, Japan | |
Recruiting | |
Kagoshima, Japan | |
Recruiting | |
Kumamoto, Japan | |
Recruiting | |
Niigata, Japan | |
Recruiting | |
Osaka, Japan | |
Japan, Aichi | |
Recruiting | |
Nagoya, Aichi, Japan | |
Japan, Chiba | |
Recruiting | |
Kashiwa, Chiba, Japan, 277-0882 | |
Japan, Ehime | |
Recruiting | |
Matsuyama, Ehime, Japan | |
Japan, Gunma | |
Recruiting | |
Ota, Gunma, Japan | |
Recruiting | |
Maebashi, Gunma, Japan | |
Japan, Hiroshima | |
Recruiting | |
Kure, Hiroshima, Japan | |
Japan, Hokkaido | |
Recruiting | |
Sapporo, Hokkaido, Japan | |
Japan, Hyogo | |
Recruiting | |
Akashi, Hyogo, Japan | |
Japan, Saitama | |
Recruiting | |
Hidaka, Saitama, Japan | |
Japan, Shizuoka | |
Recruiting | |
Hamamatsu, Shizuoka, Japan | |
Japan, Tochigi | |
Recruiting | |
Shimoto, Tochigi, Japan | |
Recruiting | |
Utsunomiya, Tochigi, Japan | |
Japan, Tokyo | |
Recruiting | |
Chuo, Tokyo, Japan, 104-0045 | |
Recruiting | |
Koto, Tokyo, Japan, 135-8550 | |
Recruiting | |
Bunkyo, Tokyo, Japan |
Study Director: | Tatsuo Watanabe | Eisai Limited |
Responsible Party: | Eisai Company Limited ( Customer Information Services Department ) |
Study ID Numbers: | E7389-J081-221 |
Study First Received: | February 4, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00633100 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Cancer breast cancer neoplasm E7389 |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |