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Clinical Trial Summary

This is a research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152.

The participants tumor will be tested for expression of this receptor (using an old biopsy). If the participants cancer does not have this receptor, participants will not be eligible to participant in this study.

AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.

Participants will continue treatment until death, disease progression, unacceptable toxicity, participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation beyond 6 cycles is left at the discretion of the study doctor.

The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37 for the Phase II portion).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01240629
Study type Interventional
Source University of Southern California
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 2, 2010
Completion date February 2, 2017

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