MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Condition: Pigmented Villonodular Synovitis; PVNS; Giant Cell Tumor of the Tendon Sheath; GCCTS; Tenosynovial Giant Cell Tumor Localized or Diffused Type; GCTS
MeSH terms: Neoplasms; Giant Cell Tumors; Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular; Synovitis
Intervention: MCS110; Placebo
Intervention description: 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.; Participants will receive a single dose of NaCl on day 1 through intravenous infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pigmented Villonodular Synovitis; PVNS; Giant cell tumor of the tendon sheath; GCCTS; Tenosynovial giant cell tumor (localized or diffused type); GCTS; MCS110

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.
    

Eligibility criteria:

        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.