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

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ET-743 in Men With Advanced Prostate Cancer

This study is currently recruiting participants.

Study NCT00072670. Last updated on September 18, 2006. Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

ET-743 in Men With Advanced Prostate Cancer

Official Title ^†

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 ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

measurement of PSA response in men with AIPC

Secondary Outcome Measure ^†

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

Condition ^†

Prostate Cancer

Intervention ^†

Drug: ET-743 (YONDELIS)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

January 2004

Completion Date

Eligibility 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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00072670

Organization ID

ET-B-025-02

Secondary IDs ^††

Study Sponsor ^†

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

Collaborators ^††

PharmaMar

Investigators ^†

Study Director:

Claudia Lebedinsky, MD

PharmaMar, SA

Information Provided By

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

Verification Date

September 2006

First Received Date ^†

November 7, 2003

Last Updated Date

September 18, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.