Phase I Combination w/ Epirubicin - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00322374

Purpose

Tumor response information will be obtained for all patients who received at least 2 cycles of study drug, undergo requisite baseline and on-treatment disease assessments and have at least one post-treatment assessment. Tumor response assessment in evaluable patients will be done according to the RECIST criteria.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Ixabepilone and Epirubicin	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ixabepilone Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Maximum Tolerated Dose [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]
Dose Limiting Toxicity [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]
Recommend a Phase II dose of ixabepilone and epirubicin in female patients with metastatic breast cancer [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Describe overall safety profile of ixabepilone-epirubicin combination [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]
Assess single-dose plasma pharmacokinetics of ixabepilone-epirubicin combination [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Assess clinical activity of ixabepilone-epirubicin combination as measured by the tumor response [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ixabepilone and Epirubicin Infusion, I.V., Dose escalation study. MTD defined as Epirubicin:75mg/m² / Ixabepilone: 30mg/m², cycle=21days, up to 10 cycles or epirubicin cumulative dose of 800mg/m²

Eligibility

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

Criteria

Inclusion Criteria:

Women > =1 8 years
Histologically or cytologically confirmed diagnosis of metastatic breast cancer
Measurable or nonmeasurable disease defined by RECIST

Exclusion Criteria:

Number of prior chemotherapy lines of treatment in the metastatic setting > = 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322374

Locations

France
Local Institution
Toulouse Cedex 3, France, 31052
Italy
Local Institution
Milano, Italy, 20133

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-104, Eudract No: 2005-004864-22
Study First Received:	May 1, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00322374
Health Authority:	Italy:Commissario Straordinario dell' Istituto Nazionale per lo Studio e la Cura dei Tumori

Study placed in the following topic categories:

Skin Diseases
Epothilones
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009