A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants Experiencing Dose Limiting Toxicity (DLT)
DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
From initiation of drug through last day of Cycle 2 (Day 42)
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Japan: Ministry of Health, Labor and Welfare
CA163-117
NCT00568022
February 2008
January 2010
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