A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00568022

Purpose

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese patients with metastatic breast cancer

Condition	Intervention	Phase
Breast Cancer	Drug: Ixabepilone + Capecitabine	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

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 Phase II dose of ixabepilone in combination with capecitabine in Japanese patients with metastatic breast cancer [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile of ixabepilone-capecitabine combination [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]
Efficacy of ixabepilone-capecitabine combination [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Pharmacokinetics of Ixabepilone [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ixabepilone + Capecitabine Ixabepilone: IV Solution, IV, 32(40)mg/m2, once every 3 weeks, up to 6 cycles Capecitabine: Tablets, Oral, 1650(2000)mg/m2, twice daily for 2 weeks, one week off, up to 6 cycles

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women ≥ 20 years
Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast

Exclusion Criteria:

Number of prior chemotherapy lines of treatment in the metastatic setting ≥3

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568022

Locations

Japan
Local Institution
Osaka, Japan, --
Japan, Ehime
Local Institution
Matsuyama-Shi, Ehime, Japan, 7910280
Japan, Gunma
Local Institution
Matabashi-Shi, Gunma, Japan, 371-8511
Japan, Shizuoka
Local Institution
Sunto-Gun, Shizuoka, Japan, 411-8777

Sponsors and Collaborators

Bristol-Myers Squibb

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:	CA163-117
Study First Received:	December 3, 2007
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00568022 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Skin Diseases
Epothilones
Tubulin Modulators

Breast Neoplasms
Antimitotic Agents
Taxane
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
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 06, 2009