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Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC

NCT02502994 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-07-20

No results posted yet for this study

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.

Conditions

  • Castration Resistant Prostate Cancer

Interventions

DRUG

GEN0101

Sponsors & Collaborators

  • Norio Nonomura

    lead OTHER

Principal Investigators

  • Norio Nonomura, MD · Urology, Osaka University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502994 on ClinicalTrials.gov