MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

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)

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.

Inclusion criteria:

• Males and Females aged ≥ 18 years (≥ 12 years in PART C) with PVNS or GCTTS with, at least, one measurable site of disease on MRI.
• Patients expected to get surgery (PART A of study only).
• Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
• Patients with normal level of serum ionized calcium and phosphate.
• Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.

Exclusion criteria:

• Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
• Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
• Use previously of intra-articular treatment within 4 weeks prior dosing.
• Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
• Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
• Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
• Patients engaged in a resistance exercise training program.
• Patients with pacemakers or any metallic objects as exclusion for MRI
• Patients with concomitant disease know to get influence on bone metabolism
• Patients who have history of drug or alcohol abuse within 12 months prior study dosing.
• Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.