Back to resultsA Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-751
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility 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.
Sites / Locations
- Oncology Hematology Group of South Florida
- Florida Cancer Institute
- University of Chicago Medical Center
- University of Maryland Greenbaum Cancer Center
- Oncology & Hematology Associates of Kansas City, PA
- Washington University School of Medicine
- Albany Regional Cancer Center
- Raleigh Hematology Oncology
- Dayton Oncology and Hematology
- Cancer Care Associates
- Cancer Centers of the Carolinas
- West Cancer Clinic
- Texas Oncology
- Texas Oncology
- Cancer Care Northwest
- Northwest Cancer Specialists
- University of Wisconsin Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Objective Response Rate in subjects with NSCLC
Secondary Outcome Measures
Time to Tumor Progression (TTP)
Survival
Toxicities associated with treatment administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00073151
Brief Title
A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
Official Title
A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABT-751
Primary Outcome Measure Information:
Title
Objective Response Rate in subjects with NSCLC
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to Tumor Progression (TTP)
Time Frame
1 year
Title
Survival
Time Frame
2 years
Title
Toxicities associated with treatment administration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Eliopoulos, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Hematology Group of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Institute
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1460
Country
United States
Facility Name
University of Maryland Greenbaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Oncology & Hematology Associates of Kansas City, PA
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Raleigh Hematology Oncology
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
Dayton Oncology and Hematology
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas Oncology
City
Ft. Worth
State/Province
Texas
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Northwest Cancer Specialists
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5666
Country
United States
12. IPD Sharing Statement
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A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
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