A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline

NCT ID: NCT01027208

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-01-31

Brief Summary

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To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ixabepilone

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Lyophilized and solvent, IV, 10-50 mg/m²

Interventions

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Ixabepilone

Lyophilized and solvent, IV, 10-50 mg/m²

Intervention Type DRUG

Other Intervention Names

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Ixempra

Eligibility Criteria

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Inclusion Criteria

* Women aged 20 years or older
* Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion Criteria

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
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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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Kashiwa-Shi, Chiba, Japan

Site Status

Local Institution

Fukuoka, Fukuoka, Japan

Site Status

Local Institution

Matabashi-Shi, Gunma, Japan

Site Status

Local Institution

Kagoshima, Kagoshima-ken, Japan

Site Status

Local Institution

Isehara-Shi, Kanagawa, Japan

Site Status

Local Institution

Niigata, Niigata, Japan

Site Status

Local Institution

Iruma-Gun, Saitama, Japan

Site Status

Local Institution

Saitama, Saitama, Japan

Site Status

Local Institution

Utsunomiya, Tochigi, Japan

Site Status

Local Institution

Bunkyo-Ku, Tokyo, Japan

Site Status

Local Institution

Chuo-Ku, Tokyo, Japan

Site Status

Local Institution

Tokyo, Tokyo, Japan

Site Status

Local Institution

Toshima-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA163-130

Identifier Type: -

Identifier Source: org_study_id

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