A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Capecitabine; Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568022

CA163-117

Details and patient eligibility

About

The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.

Enrollment: 9 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Ixabepilone + Capecitabine

Experimental group

Treatment:

Drug: Capecitabine

Drug: Ixabepilone