Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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).

Key facts

Study ID
NCT01240629
Run by
University of Southern California
People needed
43
Starts
2010-11-02
Expected to finish
2017-02-02
Last updated by the study team
2017-07-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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