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

Completed · Phase 2

Conditions studied: Non-Small-Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00085813

Run by

GlaxoSmithKline

People needed

70

Starts

2003-12-01

Expected to finish

2005-10-01

Last updated by the study team

2010-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Memphis, Tennessee, United States
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Edegem, Belgium
• GSK Investigational Site — Leuven, Belgium
• GSK Investigational Site — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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