ET-743 in Men With Advanced Prostate Cancer - Full Text View

ET-743 in Men With Advanced Prostate Cancer

This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., September 2006

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00072670

Purpose

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in men with advanced prostate cancer. After a subject meets all entry criteria and signs informed consent he will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have PSA levels measured multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study.

Condition	Intervention	Phase
Prostate Cancer	Drug: ET-743 (YONDELIS)	Phase II

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Ecteinascidin 743

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Primary Outcome Measures:

measurement of PSA response in men with AIPC

Secondary Outcome Measures:

measurement of duration of response and time to progression in men with AIPC
assessment of safety parameters

Estimated Enrollment:	50
Study Start Date:	January 2004

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Male subjects with adenocarcinoma of the prostate
Radiographically documented metastatic disease
PSA > 15 ng/ml
Performance status ECOG 0,1 or 2
Adequate bone marrow reserves, hepatic function, and renal function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072670

Locations


United States, Massachusetts
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114-2617
	Contact: M. Dror Michaelson, MD 617-724-5248

Sponsors and Collaborators

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

PharmaMar

Investigators


Study Director:	Claudia Lebedinsky, MD	PharmaMar, SA

More Information

Study ID Numbers:	ET-B-025-02
First Received:	November 7, 2003
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00072670
Health Authority:	United States: Food and Drug Administration

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

prostate cancer

Study placed in the following topic categories:

Ecteinascidin 743

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Antineoplastic Agents, Alkylating

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008