Clincosm LogoSign in Get a demo

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

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00073151
Collaborator
(none)
30
Enrollment
17
Locations
28
Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2003
Actual Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate in subjects with NSCLC [1 year]

Secondary Outcome Measures

  1. Time to Tumor Progression (TTP) [1 year]

  2. Survival [2 years]

  3. Toxicities associated with treatment administration [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oncology Hematology Group of South Florida Miami Florida United States
2 Florida Cancer Institute New Port Richey Florida United States
3 University of Chicago Medical Center Chicago Illinois United States 60637-1460
4 University of Maryland Greenbaum Cancer Center Baltimore Maryland United States 21201-1595
5 Oncology & Hematology Associates of Kansas City, PA Kansas City Missouri United States 64111
6 Washington University School of Medicine St. Louis Missouri United States 63110-1093
7 Albany Regional Cancer Center Albany New York United States
8 Raleigh Hematology Oncology Cary North Carolina United States
9 Dayton Oncology and Hematology Kettering Ohio United States
10 Cancer Care Associates Oklahoma City Oklahoma United States
11 Cancer Centers of the Carolinas Greenville South Carolina United States
12 West Cancer Clinic Memphis Tennessee United States 38120
13 Texas Oncology Dallas Texas United States
14 Texas Oncology Ft. Worth Texas United States
15 Cancer Care Northwest Spokane Washington United States
16 Northwest Cancer Specialists Vancouver Washington United States
17 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-5666

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Helen Eliopoulos, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00073151
Other Study ID Numbers:
  • M02-448
  • NCT00080730
First Posted:
Nov 18, 2003
Last Update Posted:
Nov 29, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 29, 2007