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Study Of Ispinesib In Subjects With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00089973
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : October 4, 2010
Information provided by:

Study Description
Brief Summary:

The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:

  1. Does breast cancer respond to Ispinesib?
  2. What are the side effects of Ispinesib?
  3. How much Ispinesib is in the blood at specific times after it is taken?

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ispinesib Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer
Study Start Date : June 2004
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: once every 21 days for multiple cycles ]

Secondary Outcome Measures :
  1. Pharmacokinetics Median time to response [ Time Frame: time to response ]
  2. Median duration of response [ Time Frame: duration of response ]
  3. Median time to progression after administration of Inspinesib [ Time Frame: time to progression after administration of Inspinesib ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage IIIB or Stage IV breast cancer
  • Previously received anthracycline and taxane therapy

Exclusion criteria:

  • Actively receiving anti-cancer therapy agent(s).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089973

United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32224
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 59100
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 169610
United Kingdom
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00089973     History of Changes
Other Study ID Numbers: KSP20001
First Posted: August 20, 2004    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by GlaxoSmithKline:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases