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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00085813 |
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
Condition | Intervention | Phase |
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Non-Small-Cell Lung Cancer |
Drug: Ispinesib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open-Label Study of Ispinesib in Subjects With Locally Advanced or Metastatic Platinum-Refractory or Platinum-Relapsed Non-Small Cell Lung Cancer (NSCLC) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
GSK Investigational Site | |
Scottsdale, Arizona, United States, 85259 | |
United States, Florida | |
GSK Investigational Site | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
GSK Investigational Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
GSK Investigational Site | |
Rochester, New York, United States, 14623 | |
United States, North Carolina | |
GSK Investigational Site | |
Greensboro, North Carolina, United States, 27403 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
GSK Investigational Site | |
Memphis, Tennessee, United States, 38104 | |
Belgium | |
GSK Investigational Site | |
Edegem, Belgium, 2650 | |
GSK Investigational Site | |
Leuven, Belgium, 3000 | |
GSK Investigational Site | |
Bruxelles, Belgium, 1000 | |
United Kingdom, Surrey | |
GSK Investigational Site | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | KSP20007 |
Study First Received: | June 14, 2004 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00085813 |
Health Authority: | United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines |
Platinum-Refractory Platinum-Relapsed Non-Small Cell Lung Cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |