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

November 28, 2007 updated by: Abbott

A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate in subjects with NSCLC
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

November 17, 2003

First Submitted That Met QC Criteria

November 17, 2003

First Posted (ESTIMATE)

November 18, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on ABT-751

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe