Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer

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)

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.

Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.

Inclusion Criteria: Must have received only one prior platinum-based chemotherapy regimen. Blood tests will be done to check if blood counts are adequate for taking part in the study. Exclusion Criteria: Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function. Females who are pregnant. Any unstable, pre-existing major medical condition or history of other cancers. Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.