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

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Docetaxel Paclitaxel ABT 751 E 7010

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 II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens

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

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

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Paclitaxel

Breast Neoplasms

Taxane

Breast Diseases

Recurrence

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008

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