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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate in subjects with Breast cancer

Outcome Time Frame:

1 year

Principal Investigator

Helen Eliopoulos, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M02-447

NCT ID:

NCT00063102

Start Date:

November 2002

Completion Date:

August 2004

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Oncology-Hematology Group of South Florida Miami, Florida  33176
Georgia Cancer Specialists Decatur, Georgia  30033
Texas Oncology Dallas, Texas  
Clinical Research Network, Inc. Plantation, Florida  33324
Northwestern University Medical School Division of Hematology/Oncology Chicago, Illinois  60611
Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion Indianapolis, Indiana  46202
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Oncology & Hemotology Associates of Kansas City, PA Kansas City, Missouri  64111