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NCT00063102 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00063102
Other study ID # M02-447
Secondary ID
Status Completed
Phase Phase 2
First received June 19, 2003
Last updated November 28, 2007
Start date November 2002
Est. completion date August 2004

Study information
Verified date November 2007
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-751

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

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Response Rate in subjects with Breast cancer 1 year
Secondary Time to Tumor Progression (TTP) 1 year
Secondary Survival 2 years
Secondary Toxicities associated with treatment administration 1 year
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