A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
1 other identifier
interventional
30
1 country
17
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Sep 2003
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
17 active sites
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
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 17, 2003
CompletedFirst Posted
Study publicly available on registry
November 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedNovember 29, 2007
November 1, 2007
November 17, 2003
November 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate in subjects with NSCLC
1 year
Secondary Outcomes (3)
Time to Tumor Progression (TTP)
1 year
Survival
2 years
Toxicities associated with treatment administration
1 year
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or breast feeding.
- Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
- CNS metastasis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (17)
Oncology Hematology Group of South Florida
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1460, United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
Oncology & Hematology Associates of Kansas City, PA
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1093, United States
Albany Regional Cancer Center
Albany, New York, United States
Raleigh Hematology Oncology
Cary, North Carolina, United States
Dayton Oncology and Hematology
Kettering, Ohio, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
West Cancer Clinic
Memphis, Tennessee, 38120, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-5666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helen Eliopoulos, MD
Abbott
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
November 17, 2003
First Posted
November 18, 2003
Study Start
September 1, 2003
Study Completion
January 1, 2006
Last Updated
November 29, 2007
Record last verified: 2007-11