CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
MCS110 +1 moredrug
Likely dose
MCS110 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01643850
NCT01643850Phase 2Completed
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A Phase II Randomized, Double -Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

Novartis Pharmaceuticals·interventional·Posted Jul 18, 2012·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating MCS110 and Placebo for Pigmented Villonodular Synovitis and 5 related conditions. Completed, enrolled 36 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPigmented Villonodular Synovitis, PVNS, Giant Cell Tumor of the Tendon Sheath, GCCTS, Tenosynovial Giant Cell Tumor Localized or Diffused Type, GCTS
CountriesSwitzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2012
Enrollment StartApr 23, 2012
Primary CompletionDec 7, 2017
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 14.0 years ago

Interventions

MCS110drug

Patients will receive up to 6 doses of MCS110 (3 or 5 or 10mg/kg) administered intravenously once every 4 weeks. Before each dosing, safety will be assessed.

Placebodrug

Participants will receive a single dose of NaCl on day 1 through intravenous infusion.