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

Non-Small Cell Lung Cancer

Intervention / Treatment

Drug: ABT-751

Study Type

Interventional

Enrollment (Anticipated)

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

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