NCT00063102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

June 19, 2003

Last Update Submit

November 28, 2007

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate in subjects with Breast cancer

    1 year

Secondary Outcomes (3)

  • Time to Tumor Progression (TTP)

    1 year

  • Survival

    2 years

  • Toxicities associated with treatment administration

    1 year

Interventions

ABT-751DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breast feeding.
  • No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Clinical Research Network, Inc.

Plantation, Florida, 33324, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, United States

Location

Northwestern University Medical School Division of Hematology/Oncology

Chicago, Illinois, 60611, United States

Location

Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion

Indianapolis, Indiana, 46202, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Location

Oncology & Hemotology Associates of Kansas City, PA

Kansas City, Missouri, 64111, United States

Location

Texas Oncology

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ABT751

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Helen Eliopoulos, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2003

First Posted

June 23, 2003

Study Start

November 1, 2002

Study Completion

August 1, 2004

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

US(8)