NCT01027208

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

December 4, 2009

Last Update Submit

January 27, 2017

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator

    21-day cycles until documented disease progression or unacceptable toxicity

  • To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

    21-day cycles until documented disease progression or unacceptable toxicity

Secondary Outcomes (4)

  • Secondary objectives will be assessed by combining data with the previous Phase II study CA163107

    21-day cycles until documented disease progression or unacceptable toxicity

  • To evaluate the antitumor response according to the RECIST criteria

    21-day cycles until documented disease progression or unacceptable toxicity

  • To evaluate the duration of achieved responses

    21-day cycles until documented disease progression or unacceptable toxicity

  • To evaluate time to progression (TTP)

    21-day cycles until documented disease progression or unacceptable toxicity

Study Arms (1)

Ixabepilone

EXPERIMENTAL
Drug: Ixabepilone

Interventions

IxabepiloneDRUG

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

Also known as: Ixempra
Ixabepilone

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Nagoya, Aichi-ken, 464-8681, Japan

Location

Local Institution

Kashiwa-Shi, Chiba, 277-0882, Japan

Location

Local Institution

Fukuoka, Fukuoka, Japan

Location

Local Institution

Matabashi-Shi, Gunma, 371-8511, Japan

Location

Local Institution

Kagoshima, Kagoshima-ken, 892-0833, Japan

Location

Local Institution

Isehara-Shi, Kanagawa, 259-1193, Japan

Location

Local Institution

Niigata, Niigata, 951-8566, Japan

Location

Local Institution

Iruma-Gun, Saitama, 350-0495, Japan

Location

Local Institution

Saitama, Saitama, Japan

Location

Local Institution

Utsunomiya, Tochigi, 320-0834, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Local Institution

Tokyo, Tokyo, Japan

Location

Local Institution

Toshima-Ku, Tokyo, 170-8455, Japan

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

December 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

JP(14)