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

November 28, 2007 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate in subjects with Breast cancer
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

June 19, 2003

First Submitted That Met QC Criteria

June 20, 2003

First Posted (Estimate)

June 23, 2003

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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