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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


Phase 1
20 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Women ≥ 20 years

- Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in
the breast

Exclusion Criteria:

- Number of prior chemotherapy lines of treatment in the metastatic setting ≥3

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants Experiencing Dose Limiting Toxicity (DLT)

Outcome Description:

DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.

Outcome Time Frame:

From initiation of drug through last day of Cycle 2 (Day 42)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CA163-117

NCT ID:

NCT00568022

Start Date:

February 2008

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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