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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063102
First Posted: June 23, 2003
Last Update Posted: November 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063102


Locations
United States, Florida
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Clinical Research Network, Inc.
Plantation, Florida, United States, 33324
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

ClinicalTrials.gov Identifier: NCT00063102     History of Changes
Other Study ID Numbers: M02-447
First Submitted: June 19, 2003
First Posted: June 23, 2003
Last Update Posted: November 29, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taxane
Antineoplastic Agents