A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

This study has been completed.

First Received: June 19, 2003 Last Updated: November 28, 2007 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00063102

Purpose

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Condition	Intervention	Phase
Breast Cancer	Drug: ABT-751	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: E 7010 ABT 751

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Objective Response Rate in subjects with Breast cancer [ Time Frame: 1 year ]

Secondary Outcome Measures:

Time to Tumor Progression (TTP) [ Time Frame: 1 year ]
Survival [ Time Frame: 2 years ]
Toxicities associated with treatment administration [ Time Frame: 1 year ]

Estimated Enrollment:	40
Study Start Date:	November 2002
Study Completion Date:	August 2004

Eligibility

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

Criteria

Inclusion Criteria

Stage IIIB or IV breast cancer.
Recurrent tumor after or while on taxane therapy (taxol or taxotere).
Able to tolerate normal activities of daily living.
Adequate bone marrow, kidney and liver function.

Exclusion Criteria

Pregnant or breast feeding.
No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063102

Locations

United States, Florida
Clinical Research Network, Inc.
Plantation, Florida, United States, 33324
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States
United States, Illinois
Northwestern University Medical School Division of Hematology/Oncology
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion
Indianapolis, Indiana, United States, 46202
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
United States, Missouri
Oncology & Hemotology Associates of Kansas City, PA
Kansas City, Missouri, United States, 64111
United States, Texas
Texas Oncology
Dallas, Texas, United States

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, MD

Abbott

More Information

No publications provided

Study ID Numbers:	M02-447
Study First Received:	June 19, 2003
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00063102 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009