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

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00063102
Collaborator
(none)
40
Enrollment
8
Locations
21
Duration (Months)
5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
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
Study Start Date :
Nov 1, 2002
Actual Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate in subjects with Breast cancer [1 year]

Secondary Outcome Measures

  1. Time to Tumor Progression (TTP) [1 year]

  2. Survival [2 years]

  3. Toxicities associated with treatment administration [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Oncology-Hematology Group of South Florida Miami Florida United States 33176
2 Clinical Research Network, Inc. Plantation Florida United States 33324
3 Georgia Cancer Specialists Atlanta Georgia United States
4 Northwestern University Medical School Division of Hematology/Oncology Chicago Illinois United States 60611
5 Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion Indianapolis Indiana United States 46202
6 Northern Indiana Cancer Research Consortium South Bend Indiana United States
7 Oncology & Hemotology Associates of Kansas City, PA Kansas City Missouri United States 64111
8 Texas Oncology Dallas Texas United States

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Helen Eliopoulos, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00063102
Other Study ID Numbers:
  • M02-447
First Posted:
Jun 23, 2003
Last Update Posted:
Nov 29, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 29, 2007