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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00085813

Collaborator

(none)

Enrollment

Locations

Duration (Months)

6.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer	Drug: Ispinesib	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Scottsdale	Arizona	United States	85259
2	GSK Investigational Site	Jacksonville	Florida	United States	32224
3	GSK Investigational Site	Rochester	Minnesota	United States	55905
4	GSK Investigational Site	Rochester	New York	United States	14623
5	GSK Investigational Site	Greensboro	North Carolina	United States	27403
6	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19111
7	GSK Investigational Site	Memphis	Tennessee	United States	38104
8	GSK Investigational Site	Bruxelles		Belgium	1000
9	GSK Investigational Site	Edegem		Belgium	2650
10	GSK Investigational Site	Leuven		Belgium	3000
11	GSK Investigational Site	Sutton	Surrey	United Kingdom	SM2 5PT