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

NCT00568022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-03-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ixabepilone

Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles

DRUG

Capecitabine

Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00568022 on ClinicalTrials.gov