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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
Not Enrolling
Both
Non-Small-Cell Lung Cancer

Thank you

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 SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021