ET-743 in Men With Advanced Prostate Cancer

This study is currently recruiting participants.

Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., June 2009

First Received: November 7, 2003 Last Updated: June 17, 2009 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate 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.:

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

No publications provided

Study ID Numbers:	ET-B-025-02
Study First Received:	November 7, 2003
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00072670 History of Changes
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

Antineoplastic Agents, Alkylating
Genital Diseases, Male
Alkylating Agents
Prostatic Neoplasms

Additional relevant MeSH terms:

Ecteinascidin 743
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Prostatic Neoplasms
Alkylating Agents

ClinicalTrials.gov processed this record on July 02, 2009