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

NCT ID: NCT00568022

Last Updated: 2016-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ixabepilone + Capecitabine

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

Interventions

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Ixabepilone

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Other Intervention Names

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IXEMPRA BMS-247550

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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R-Pharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Matsuyama, Ehime, Japan

Site Status

Local Institution

Maebashi, Gunma, Japan

Site Status

Local Institution

Osaka, Osaka, Japan

Site Status

Local Institution

Sunto-Gun, Shizuoka, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA163-117

Identifier Type: -

Identifier Source: org_study_id

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