We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Of Ispinesib In Subjects With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00089973
First Posted: August 20, 2004
Last Update Posted: October 12, 2017
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.
Information provided by:
GlaxoSmithKline
  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
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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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, 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
GlaxoSmithKline
Investigators
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 Submitted: August 18, 2004
First Posted: August 20, 2004
Last Update Posted: October 12, 2017
Last Verified: October 2010

Keywords provided by GlaxoSmithKline:
breast cancer

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