drugset / Trial / NCT01620515

Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

NCT01620515

Phase 2 Completed 141 enrolled Nymox Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.

Timeline

Start
2012-02-21
Primary completion
2015-10-21
Completion
2015-10-21

Drugs

EvaluationDrugModalityDoseRoute
Subject FEXAPOTIDE Protein / enzyme biologic 2.5 mg Other
Subject FEXAPOTIDE Protein / enzyme biologic 15 mg Other

Indications