Text Size

Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00452673
First received: March 26, 2007
Last updated: March 28, 2013
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline


Condition Intervention Phase
Advanced Breast Cancer
 Drug: Dasatinib + Capecitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To identify major toxicities [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate efficacy through objective response, response duration, and progression-free survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Collect immunohistochemical and pharmacogenomic data [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Collect plasma samples for angiogenesis [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Dasatinib + Capecitabine
Tablets, Oral, 50-100 mg. + 660-1250 mg/M2, twice daily, treatment may continue until disease progression
Other Names:
  • Sprycel
  • BMS-354825

  Eligibility

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

Inclusion Criteria:

  • Female with advanced breast cancer previously treated with a taxane and an anthracycline
  • No pleural or pericardial effusion
  • Not receiving anticoagulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452673

Locations
Italy
Local Institution
Genova, Italy, 16132
Spain
Local Institution
Barcelona, Spain, 08035
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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
ClinicalTrials.gov Identifier: NCT00452673     History of Changes
Other Study ID Numbers: CA180-004, EUDRACT: 2006-006973-26
Study First Received: March 26, 2007
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Dasatinib
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013