Completed

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

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What is being tested

Ispinesib

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2004

Actual date on which the first participant was enrolled.

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?

Official TitlePhase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer
NCT00089973
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

2 inclusion criteria required to participate
Stage IIIB or Stage IV breast cancer
Previously received anthracycline and taxane therapy
1 exclusion criteria prevent from participating
Actively receiving anti-cancer therapy agent(s).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Females with advanced or metastatic breast cancer were administered Ispinesib

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Suspended

GSK Investigational Site

Jacksonville, United StatesOpen GSK Investigational Site in Google Maps
Suspended

GSK Investigational Site

Indianapolis, United States
Suspended

GSK Investigational Site

Chapel Hill, United States
Suspended

GSK Investigational Site

Pittsburgh, United States
Completed13 Study Centers