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

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ClinicalTrials.gov Identifier: NCT00073151
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : November 29, 2007
Sponsor:
Information provided by:
Abbott

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: ABT-751 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
Study Start Date : September 2003
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Objective Response Rate in subjects with NSCLC [ Time Frame: 1 year ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073151


Locations
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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
Oncology & Hematology Associates of Kansas City, PA
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
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
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
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Study Director: Helen Eliopoulos, MD Abbott

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ClinicalTrials.gov Identifier: NCT00073151     History of Changes
Obsolete Identifiers: NCT00080730
Other Study ID Numbers: M02-448
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms