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

Non-Small-Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085813
• Other study ID #: KSP20007
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2004
• Last updated: October 1, 2010
• Start date: December 2003
• Est. completion date: October 2005

Study information

• Verified date: October 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• Ispinesib

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Leuven
United Kingdom	GSK Investigational Site	Sutton	Surrey
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Overall Response Rate of tumor.
Secondary	Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.