NCT01738360

Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary objectives : * To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE, * To determine the maximum tolerated dose of ATO. Secondary objectives : * Evaluation of the clinical and biological response of the SLE to ATO, * Time of relapse in case of positive response, * Determination of the efficacy, * Pharmacokinetic study of ATO.

Conditions

• Systemic Lupus

Interventions

Type	Name	Description
DRUG	Arsenic trioxide	The study duration was 30 months (24 months recruitment + 6 months follow-up).Thirteen patients will be successively included in this study at 6 different dose levels of arsenic trioxide (0.075, 0.10, 015, 0.20, 0.25 and 0.30 mg / kg / day). The treatment should be administered by IV infusion over 2 hours of D1 to D4 (conventional hospitalization) and at D8, D11, D15, D18, D22 and D25. The protocol starts at the dose of 0.10 mg / kg / day. The stage at the dose of 0.075mg/kg/day is planned in case of toxicity with the first stage at the dose of 0.10mg/kg/day. The course of study is as follows : * Pre-inclusion between D-35 and D-15 * Ten injections during the first month distributed as follows : conventional hospitalization from D1 to D4 (one injection per day) and daily hospitalization day for injections at D8, D11, D15, D18, D22 and D25. * A telephone contact between D32 and D34 * A consultation at D40 then monthly consultation at D60, D90, D120, D150 and D180

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-11-30
• Last updated: 2016-01-06

Locations

6 sites across 1 country: France