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Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC

Castration Resistant Prostate Cancer Clinical Trial

Official title:
Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients With Recurrence of Castration Resistant Prostate Cancer

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer.

The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period.

Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02502994
Study type Interventional
Source Osaka University
Contact Norio Nonomura, MD
Phone +81668793531
Email nono@uro.med.osaka-u.ac.jp
Status Recruiting
Phase Phase 1
Start date May 2015
View Details
See also
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