Phase II Trial of Weekly or Every 3-Week Ixabepilone for Patients With Metastatic Breast Cancer (MBC)

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, February 2009

First Received: January 4, 2008 Last Updated: May 6, 2009 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb US Oncology Research
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00593827

Purpose

The purpose of this study is to find out what effects different schedules of ixabepilone has on the patient and her metastatic breast cancer

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Ixabepilone	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Randomized Trial of Weekly and Every 3-Week Ixabepilone in Metastatic Breast Cancer (MBC) Patients

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Determine the proportion of patients who are progression free [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Median progression free survival [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Overall response rate in patients with measurable disease [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: determined after patients have been followed for one-year post treatment ] [ Designated as safety issue: No ]
Incidence of all grades of peripheral neuropathy [ Time Frame: as assessed throughout study as well as at the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	148
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator 16mg/m2, weekly for 3/4 weeks	Drug: Ixabepilone Injection, IV, Until progressive disease or intolerable toxicity
Arm 2: Active Comparator 40mg/m2, every 3 weeks	Drug: Ixabepilone Injection, IV, Until progressive disease or intolerable toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
Has HER2 negative breast cancer
Prior chemotherapy is permitted with no limit on the number of prior regimens
Two weeks or more have elapsed since last chemotherapy or radiation treatment
Has an ECOG PS of 0-2
Is female, ≥ 18 yrs of age
Protocol defined appropriate laboratory values
Negative pregnancy test within 7 calendar days prior to registration
Has signed a patient informed consent

Exclusion Criteria:

Had prior treatment with Ixabepilone or other epothilones
Has HER2+ disease
Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
Has peripheral neuropathy > grade 1
Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible
Is pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593827

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 57 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

US Oncology Research

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-132, USOR 06-106
Study First Received:	January 4, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00593827 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Epothilones
Tubulin Modulators

Breast Neoplasms
Antimitotic Agents
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009