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

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

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

ABT 751 E 7010

U.S. FDA Resources

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

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

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