A Phase II Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer Previously Treated With Fluoropyrimidine-based Chemotherapy
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.
During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)
Japan: Pharmaceuticals and Medical Devices Agency