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

Tracking Information

First Received Date ^ICMJE

June 19, 2003

Last Updated Date

November 28, 2007

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Response Rate

Change History

Complete list of historical versions of study NCT00063102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Time to Tumor Progression (TTP)
Survival
Toxicities associated with treatment administration

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: ABT-751

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00063102

Responsible Party

Study ID Numbers ^ICMJE

M02-447

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Helen Eliopoulos, MD

Abbott

Information Provided By

Abbott

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP