A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00073151

Purpose

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 non-small cell lung cancer. 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	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: ABT-751	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: E 7010 ABT 751

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	September 2003
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Stage IIIB or IV non-small cell lung cancer.
Recurrent tumor following treatment with paclitaxel or docetaxel.
Able to tolerate normal activities of daily living.
Adequate bone marrow, kidney and liver function.

Exclusion Criteria

Pregnant or breast feeding.
Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
CNS metastasis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073151

Locations

United States, Florida
Oncology Hematology Group of South Florida
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1460
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
Oncology & Hematology Associates of Kansas City, PA
Kansas City, Missouri, United States, 64111
United States, New York
Albany Regional Cancer Center
Albany, New York, United States
United States, North Carolina
Raleigh Hematology Oncology
Cary, North Carolina, United States
United States, Ohio
Dayton Oncology and Hematology
Kettering, Ohio, United States
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
United States, Tennessee
West Cancer Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Oncology
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology
Ft. Worth, Texas, United States
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-5666

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, MD

Abbott

More Information

No publications provided

Study ID Numbers:	M02-448
Study First Received:	November 17, 2003
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00073151 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Taxane
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009