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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00085813

Purpose

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
Non-Small-Cell Lung Cancer	Drug: Ispinesib	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Ispinesib

U.S. FDA Resources

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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Assessment of Overall Response Rate of tumor.

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085813

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

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

Keywords provided by GlaxoSmithKline:

Platinum-Refractory
Platinum-Relapsed
Non-Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009