MedTrace Logo

MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

NCT01643850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-05

Study results available
· View outcomes & findings →

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.

Conditions

  • Pigmented Villonodular Synovitis
  • PVNS
  • Giant Cell Tumor of the Tendon Sheath
  • GCCTS
  • Tenosynovial Giant Cell Tumor Localized or Diffused Type
  • GCTS

Interventions

DRUG

MCS110

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.

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-23
Primary Completion
2017-12-07
Completion
2018-12-21
FDA Drug
Yes

Countries

  • United States
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643850 on ClinicalTrials.gov