Continuation Study of E7389 for Advanced or Relapsed Breast Cancer
The purpose of this study is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Continuation Study of E7389 for Advanced or Relapsed Breast Cancer|
- Occurrence of adverse events, changes in physical examination findings, laboratory test results, vital signs, and electrocardiogram evaluations. [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
- Objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) and duration of overall response [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Experimental: E7389 1.4 mg/m2||
E7389 1.4 mg/m2 is administrated intravenously. In this study, the initial dose will be administered within 14 days after Day 22 of the last cycle in the preceding study. One cycle will consist of 21 days, and in each cycle E7389 will be administered on Days 1 and 8 and withdrawn on Day 15.
During the period of E7389 administration, the following items will be examined to evaluate the safety of E7389: signs and symptoms, clinical laboratory parameters, chest x-ray findings, 12-lead ECG, vital signs, body weight, and adverse events. To evaluate the efficacy of E7389, tumor lesions will be observed and tumor markers will be examined.
|Nagoya, Aichi, Japan|
|Kure, Hiroshima, Japan|
|Chuo, Tokyo, Japan|
|Study Director:||Tatsuo Watanabe||Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd|