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

Phase 1

Completed

• Conditions: Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Prostate Cancer; Stage IV Prostate Cancer
• Interventions: Other: laboratory biomarker analysis; Other: questionnaire administration; Drug: doxorubicin-GnRH agonist conjugate AEZS-108

• Registration Number: NCT01240629
• Lead Sponsor: University of Southern California

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-30
• Study Start: 2010-11-02
• Study First Submitted QC: 2010-11-11
• Study First Posted: 2010-11-15
• Primary Completion: 2017-02-02
• Study Completion: 2017-02-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	questionnaire administration	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.
Arm I	laboratory biomarker analysis	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.
Arm I	doxorubicin-GnRH agonist conjugate AEZS-108	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.

Primary Outcome Measures

Name	Time	Method
Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment	At 3 months up to 24 months

Secondary Outcome Measures

Name	Time	Method
Response for patients with measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST)	At 3 months up to 24 months
To assess the prostate specific antigen (PSA) response rate in patients treated with AN-152	At 3 months up to 24 months
Time to PSA progression	Up to 24 months
Time to overall disease progression	Up to 24 months
Number of participants with adverse events as a measure of safety and tolerability	At 3 weeks up to 72 weeks
Overall survival	Up to 2 years

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States