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ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

NCT00496379 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-03-14

Study results available
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Summary

The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.

Conditions

Interventions

DRUG

ZK219477

Given intravenously over approximately 30 minutes once every 3 weeks

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Nancy Lin, MD

    lead OTHER

Principal Investigators

  • Nancy Lin, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-10-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496379 on ClinicalTrials.gov