Phase II Continuation Study of E7389 for Advanced or Relapsed Breast Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of adverse events, changes in physical examination findings, laboratory test results, vital signs, and electrocardiogram evaluations.
Every week
Yes
Tatsuo Watanabe
Study Director
Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
Japan: Pharmaceuticals and Medical Devices Agency
E7389-J081-224
NCT00965523
August 2009
November 2010
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