ET-743 in Subjects With Advanced Breast Cancer

This study has been completed.

First Received: December 9, 2002 Last Updated: September 20, 2007 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00050427

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: ET-743	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ecteinascidin 743

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Study Start Date:

November 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050427

Locations

United States, California

Torrance, California, United States, 90505
United States, Connecticut

Stamford, Connecticut, United States, 06902
United States, Louisiana

New Orleans, Louisiana, United States, 70115

Metairie, Louisiana, United States, 70006
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee

Nashville, Tennessee, United States, 37232-6868

Sponsors and Collaborators

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

PharmaMar

Investigators

Investigator:

J&J PRD

More Information

No publications provided

Study ID Numbers:	ET743-INT-3
Study First Received:	December 9, 2002
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00050427 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

advanced breast cancer
breast cancer
breast
cancer

Additional relevant MeSH terms:

Ecteinascidin 743
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Breast Neoplasms
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009