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)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Cancer
Both
Non-Small-Cell Lung Cancer
Trial Information
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)
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assessment of Overall Response Rate of tumor.
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
KSP20007
NCT ID:
NCT00085813
Start Date:
December 2003
Completion Date:
October 2005
Related Keywords:
- Non-Small-Cell Lung Cancer
- Platinum-Refractory
- Platinum-Relapsed
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Duluth, Minnesota 55805 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | New York, New York 10021 |
