Spots Global Cancer Trial Database for Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC
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Trial Identification
Brief Title: Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC
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
Study ID: NCT02502994
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology, Osaka University Hospital, Suita, Osaka, Japan
Contact Details
Name: Norio Nonomura, MD
Affiliation: Urology, Osaka University Hospital
Role: STUDY_CHAIR
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