drugset / Trial / NCT02866916

Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)

NCT02866916 ↗

Phase 1 Withdrawn Institut Claudius Regaud
NaSingle-groupOpen-labelTreatment

Summary

This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer. A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.

Timeline

Start
2017-09
Primary completion
2020-06
Completion
2020-06

Outcome

Outcome not reported

Stopped: “Study cancelled”

Drugs

EvaluationDrugModalityDoseRoute
Subject SXL01 Small interfering RNA (siRNA) — Subcutaneous