Clinical trial · Interventional
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)
NCT01643850CI-TRIAL-00049259completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GCCTS | — | UNRESOLVED | — |
| GCTS | — | UNRESOLVED | — |
| Giant Cell Tumor of the Tendon Sheath | — | UNRESOLVED | — |
| Pigmented Villonodular Synovitis | Tenosynovial Giant Cell Tumor, Diffuse Type | ALIAS | 0.90 |
| PVNS | — | UNRESOLVED | — |
| Tenosynovial Giant Cell Tumor Localized or Diffused Type | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCS110 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- MCS110
- description
- Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion.
- interventionNames
- Drug: MCS110
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Part A: single-dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion) Part B: single dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion administered i.v. at Day 1, followed by 6 doses of placebo to match MCS110 (10 mg/kg)
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- MCS110 3 mg/kg
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBlay JY, El Sayadi H, Thiesse P, Garret J, Ray-Coquard I. Complete response to imatinib in relapsing pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT). Ann Oncol. 2008 Apr;19(4):821-2. doi: 10.1093/annonc/mdn033. Epub 2008 Feb 21. No abstract available. PMID 18296418