Study Of Ispinesib In Subjects With Breast Cancer

NCT ID: NCT00089973

Last Updated: 2018-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Breast

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SB-715992

Females with advanced or metastatic breast cancer were administered Ispinesib

Group Type EXPERIMENTAL

Ispinesib

Intervention Type DRUG

Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ispinesib

Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Actively receiving anti-cancer therapy agent(s).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Bandar Tun Razak, Cheras, , Malaysia

Site Status

GSK Investigational Site

Bandar Tun Razak, Cheras, , Malaysia

Site Status

GSK Investigational Site

Singapore, , Singapore

Site Status

GSK Investigational Site

Singapore, , Singapore

Site Status

GSK Investigational Site

Southampton, Hampshire, United Kingdom

Site Status

GSK Investigational Site

Manchester, Lancashire, United Kingdom

Site Status

GSK Investigational Site

Newcastle upon Tyne, Northumberland, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Malaysia Singapore United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KSP20001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.