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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00085813
First received: June 14, 2004
Last updated: October 1, 2010
Last verified: October 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ispinesib
    Other Name: Ispinesib
  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
Bruxelles, Belgium, 1000
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Leuven, Belgium, 3000
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00085813     History of Changes
Other Study ID Numbers: KSP20007
Study First Received: June 14, 2004
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by GlaxoSmithKline:
Platinum-Refractory
Platinum-Relapsed
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014