Conditions: Pigmented Villonodular Synovitis PVNS Giant Cell Tumor of the Tendon Sheath GCCTS Tenosynovial Giant Cell Tumor Localized or Diffused Type GCTS
Keywords: Pigmented Villonodular Synovitis PVNS Giant cell tumor of the tendon sheath GCCTS Tenosynovial giant cell tumor (localized or diffused type) GCTS MCS110
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion. arm 2: 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) arm 3: Part C: MCS110 3 mg/kg (i.v. infusion) arm 4: Part C: MCS110 5 mg/kg (i.v. infusion) arm 5: Part C: MCS110 10 mg/kg (i.v. infusion) arm 6: Part C: MCS110 3 mg/kg (i.v. infusion) \& MCS110 10 mg/kg (i.v. infusion) arm 7: Part C: MCS110 5 mg/kg (i.v. infusion) \& MCS110 10 mg/kg (i.v. infusion)

Interventions: intervention 1: MCS110 intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Participants will receive a single dose of NaCl on day 1 through intravenous infusion.

Protocol document:
Prot_000.pdf: 
Novartis Institutes for BioMedical Research
MCS110
Clinical Trial Protocol CMCS110X2201
A Phase II randomized, double-blind (Part A, B and C), 
placebo controlled (Part A and B only), study to assess 
safety, tolerability and efficacyof MCS110 on tumor size in 
patients with pigmented villonodular synovitis (PVNS)
Document type:
Amended Protocol Version
EUDRACT number:
2011-002951-32
Version number:
v07(incorporating Amendment 07)(Clean)
Development phase:
II
Release date:
03-Jul-2018
Property of Novartis
Confidential
May not be used, divulged, published, or otherwise disclosed
without the consent of Novartis



















































































































































































































































































































SAP_001.pdf: