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Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer


Inclusion Criteria:



- Stage IIIB or Stage IV breast cancer

- Previously received anthracycline and taxane therapy

Exclusion criteria:

- Actively receiving anti-cancer therapy agent(s).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the overall response rate following administration of Ispinesib as a single, intravenous infusion once every 21 days for multiple cycles in subjects with breast cancer following treatment with both anthracycline and taxane-based chemotherapy.

Outcome Time Frame:

once every 21 days for multiple cycles

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

KSP20001

NCT ID:

NCT00089973

Start Date:

June 2004

Completion Date:

August 2006

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SitePittsburgh, Pennsylvania  15213