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)
Abstract
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.
Primary outcome: Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size; Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size; Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size; Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size; Number of Participants With Adverse Events.
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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