Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
| Verified date | November 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Regional Cancer Center | Albany | New York |
| United States | University of Maryland Greenbaum Cancer Center | Baltimore | Maryland |
| United States | Raleigh Hematology Oncology | Cary | North Carolina |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Texas Oncology | Dallas | Texas |
| United States | Texas Oncology | Ft. Worth | Texas |
| United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
| United States | Oncology & Hematology Associates of Kansas City, PA | Kansas City | Missouri |
| United States | Dayton Oncology and Hematology | Kettering | Ohio |
| United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
| United States | West Cancer Clinic | Memphis | Tennessee |
| United States | Oncology Hematology Group of South Florida | Miami | Florida |
| United States | Florida Cancer Institute | New Port Richey | Florida |
| United States | Cancer Care Associates | Oklahoma City | Oklahoma |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Northwest Cancer Specialists | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate in subjects with NSCLC | 1 year | ||
| Secondary | Time to Tumor Progression (TTP) | 1 year | ||
| Secondary | Survival | 2 years | ||
| Secondary | Toxicities associated with treatment administration | 1 year |
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