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.
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.
Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
Japan: Pharmaceuticals and Medical Devices Agency