NCT01240629

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

A Phase I/II Trial of AN-152 [AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative study
OTHER	questionnaire administration	Correlative study
DRUG	doxorubicin-GnRH agonist conjugate AEZS-108	Given IV

Timeline

• Start date: 2010-11-02
• Primary completion: 2017-02-02
• Completion: 2017-02-02
• First posted: 2010-11-15
• Last updated: 2017-07-11

Locations

1 site across 1 country: United States