NCT02866916

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

Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Cancer, Castration-Resistant

Interventions

Type	Name	Description
DRUG	SXL01	Treatment will be administered continuously over 24h through the subcutaneous route.

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2016-08-15
• Last updated: 2021-01-20

Locations

1 site across 1 country: France