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Phenelzine in Non-metastatic Recurrent Prostate Cancer
NCT02217709Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- University of Southern California
- Modality
- Small Molecules
- Drugs
- phenelzine
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of phenelzine in prostate cancer (PCa), sponsored by University of Southern California. Primary endpoints: Number of Patients With PSA Decline of >= 50% From Baseline at 12 months and Number of Patients With PSA Decline of >= 30% From Baseline at 12 months. Started Sep 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (phenelzine sulfate)
Patients receive phenelzine sulfate 30 mg PO BID.
03
Who it enrols
Men with non-metastatic recurrent prostate cancer following primary therapy, with rising PSA levels, adequate organ function, and no history of major psychiatric illness or uncontrolled hypertension.
04
Endpoints
Primary
Number of Patients With PSA Decline of >= 50% From Baseline
Number of Patients With PSA Decline of >= 30% From Baseline
Secondary
Percent of Common Toxicities Observed
Time to Radiographic Disease Progression
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