Study Of Ispinesib In Subjects With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089973
First received: August 18, 2004
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Ispinesib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • Pharmacokinetics Median time to response [ Time Frame: time to response ]
  • Median duration of response [ Time Frame: duration of response ]
  • Median time to progression after administration of Inspinesib [ Time Frame: time to progression after administration of Inspinesib ]

Enrollment: 55
Study Start Date: June 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ispinesib
    Other Name: Ispinesib
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089973

Locations
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
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 59100
Singapore
GSK Investigational Site
Singapore, Singapore, 169610
GSK Investigational Site
Singapore, Singapore, 119074
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00089973     History of Changes
Other Study ID Numbers: KSP20001
Study First Received: August 18, 2004
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Malaysia: ENHESA

Keywords provided by GlaxoSmithKline:
breast cancer

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

ClinicalTrials.gov processed this record on April 17, 2014