Clinical Trial: MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Randomized, Double-blind (Part A, B and C), Placebo Controlled (Part A and B Only), Study to Assess Safety, Tolerability and Efficacy of MCS110 on Tumor Size in Patients With

  • Change in pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCTTS) tumor size [ Time Frame: 8 weeks post last dose ]
    Primary endpoint is assessment of efficacy of multiple i.v. doses of MCS110 in reducing the volume of PVNS or GCTTS tumors evaluated by MRI after 8 weeks post last dose.
  • Number of participants with adverse events [ Time Frame: 8 weeks post last dose. ]
    Primary endpoint is assessment of safety and tolerability of multiple i.v. doses of MCS110 in this population.


    • Original Primary Outcome:

    • Change in pigmented villonodular synovitis (PVNS) tumor size [ Time Frame: week 4 ]
      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)
    • Number of participants with adverse events [ Time Frame: week 4 ]
      adverse events assessment


    Current Secondary Outcome:

    • Pharmacokinetics of MCS110 and best estimates for key PK parameters including [not limited to] area under the serum concentration-time curve (AUC), clearance (CL), apparent volume of distribution (V), mean residence time (MRT), half-lives (T1/2), etc [ Time Frame: up 104 weeks ]
      Pharmacokinetic characterization of multiple doses of MCS110
    • Evaluation of macrophage-colony stimulating factor (MCSF) plasma concentrations over time [ Time Frame: up to 104 weeks ]
      Pharmacodynamic characterization of multiple doses of MCS110
    • Change in Serum C-terminal Type 1 collagen peptide concentrations [ Time Frame: up to 104 weeks ]
      Pharmacodynamic characterization of multiple doses of MCS110
    • Change in Joint range of motion score [ Time Frame: up to 104 weeks ]
      Assessment of the duration of the clinical response
    • Change in EQ5D, mHAQ and joint specific questionnaires score [ Time Frame: up to 104 weeks ]
      Assessment of the degree of functional recovery
    • Change in serum anti-MCS110 antibody concentrations [ Time Frame: up to 104 weeks ]
      Assessment of the immunogenicity
    • Change of joint pain using a visual analog scale (VAS) [ Time Frame: up to 104 weeks ]
      Assessment of joint pain
    • Time to surgery [ Time Frame: up to 104 weeks ]
      Assessment time to surgery
    • Time to relapse [ Time Frame: up to 104 weeks ]
      Assessment time to relapse based on MRI.


    Original Secondary Outcome:

    • Pharmacokinetics of MCS110 and best estimates for key PK parameters including [not limited to] area under the serum concentration-time curve (AUC), clearance (CL), apparent volume of distribution (V), mean residence time (MRT), half-lives (T1/2), etc [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Pharmacokinetic characterization of a single dose of MCS110
    • Evaluation of macrophage-colony stimulating factor (MCSF) plasma concentrations over time [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Pharmacodynamic characterization of a single dose of MCS110
    • Change in Serum C-terminal Type 1 collagen peptide concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Pharmacodynamic characterization of a single dose of MCS110
    • Number of CD14+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Pharmacodynamic characterization of a single dose of MCS110
    • Number of CD14+ CD16+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Pharmacodynamic characterization of a single dose of MCS110
    • Change in Joint range of motion score [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Assessment of the duration of the clinical response
    • Change in Western Ontario-McMaster Arthritis (WOMAC) score [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Assessment of the duration of the clinical response
    • Change in serum anti-MCS110 antibody concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ]
      Assessment of the immunogenicity


    Information By: Novartis

    Dates:
    Date Received: March 8, 2012
    Date Started: April 23, 2012
    Date Completion: September 26, 2019
    Last Updated: May 3, 2017
    Last Verified: May 2017