Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
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).
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Other: laboratory biomarker analysis
Other: questionnaire administration
Drug: doxorubicin-GnRH agonist conjugate AEZS-108
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of AN-152 [AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer|
- Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment [ Time Frame: At 3 months up to 24 months ] [ Designated as safety issue: No ]
- Time to overall disease progression [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Response for patients with measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At 3 months up to 24 months ] [ Designated as safety issue: No ]
- To assess the prostate specific antigen (PSA) response rate in patients treated with AN-152 [ Time Frame: At 3 months up to 24 months ] [ Designated as safety issue: No ]
- Time to PSA progression [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: At 3 weeks up to 72 weeks ] [ Designated as safety issue: Yes ]
- Pain palliation defined as a 2-point decrease in pain scale of 1-10 without concomitant increase in analgesic medication use (Correlative study) [ Time Frame: At 3 weeks up to 72 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studyOther: questionnaire administration
Correlative studyDrug: doxorubicin-GnRH agonist conjugate AEZS-108
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240629
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033-0804|
|Principal Investigator:||Jacek Pinski||University of Southern California|