drugset / Trial / NCT01643850

MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

NCT01643850

Phase 2 Completed 36 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, assessed the clinical response to MCS110 treatment in Pigmented Villonodular Synovitis (PVNS) patients, after a single or multiple intravenous doses of MCS110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.

Timeline

Start
2012-04-23
Primary completion
2017-12-07
Completion
2018-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject MCS110 Monoclonal antibody 3 mg/kg Intravenous
Subject MCS110 Monoclonal antibody 5 mg/kg Intravenous
Subject MCS110 Monoclonal antibody 10 mg/kg Intravenous