Study Of Ispinesib In Subjects With Breast Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Breast

Treatments: Drug: Ispinesib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089973

KSP20001

Details and patient eligibility

About

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?

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SB-715992

Experimental group

Description:

Females with advanced or metastatic breast cancer were administered Ispinesib

Treatment:

Drug: Ispinesib