ET-743 in Men With Advanced Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 7, 2003

Last Updated Date

July 14, 2009

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

measurement of PSA response in men with AIPC

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00072670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

ET-743 in Men With Advanced Prostate Cancer

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: ET-743 (YONDELIS)

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

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

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

NCT00072670

Responsible Party

Study ID Numbers ^ICMJE

ET-B-025-02

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

PharmaMar

Investigators ^ICMJE

Study Director:

Claudia Lebedinsky, MD

PharmaMar, SA

Information Provided By

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

Verification Date

July 2009

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