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CompletedNCT01019577Updated Jan 30, 2017

Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

A Phase 2 interventional study of Ixabepilone in Metastatic Breast Cancer, sponsored by R-Pharm. Completed. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by R-Pharm · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
20 Years and older
Sex
Female
01

Study summary

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

02

Conditions studied

  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 54 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

R-Pharm is the lead sponsor of 58 studies on the registry; 2 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Ixabepilone

    Drug: Ixabepilone

Interventions

  • DrugIxabepilone

    Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles

    Also known as: Ixempra, BMS-247550

06

What researchers measure

Primary outcomes

  1. To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

Secondary outcomes

  1. To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria

    Time frame: Every cycle

  2. To evaluate the duration of achieved responses

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

  3. To evaluate time to progression (TTP)

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2005, a primary completion of Jul 2007 and a completion of Jul 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2009
First posted
Nov 25, 2009
Start
Oct 2005
Primary completionActual
Jul 2007
CompletionActual
Jul 2007
Last update
Jan 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01019577
Lead sponsor
R-Pharm
First posted
Nov 25, 2009
Start date
Oct 2005
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jan 30, 2017

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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