ET-743 in Subjects With Advanced Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

December 9, 2002

Last Updated Date

September 20, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00050427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

ET-743 in Subjects With Advanced Breast Cancer

Official Title ^ICMJE

A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer

Brief Summary

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced breast cancer. After a subject meets all entry criteria and signs informed consent she will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have thier status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: ET-743

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Female subjects 18 years of age or older
Diagnosis of advanced breast cancer
Prior therapy with anthracycline and taxane
At least one measureable tumor lesion
Adequate bone marrow, hepatic and renal function
Performance status ECOG 0 or 1

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00050427

Responsible Party

Study ID Numbers ^ICMJE

ET743-INT-3

Study Sponsor ^ICMJE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators ^ICMJE

PharmaMar

Investigators ^ICMJE

Investigator:

J&J PRD

Information Provided By

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP