MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/13/2019 |
Start Date: | April 23, 2012 |
End Date: | December 21, 2018 |
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)
This study, designed as a proof of concept study of MCS110 in pigmented villonodular
synovitis, will assess the clinical response to MCS110 treatment in newly diagnosed Pigmented
Villonodular Synovitis (PVNS) patients within 4 weeks after a single intravenous dose of
MCS110 using magnetic resonance imaging to assess tumor volume, and to evaluate
pharmacokinetics/pharmacodynamics, safety and tolerability in this population.
synovitis, will assess the clinical response to MCS110 treatment in newly diagnosed Pigmented
Villonodular Synovitis (PVNS) patients within 4 weeks after a single intravenous dose of
MCS110 using magnetic resonance imaging to assess tumor volume, and to evaluate
pharmacokinetics/pharmacodynamics, safety and tolerability in this population.
Inclusion criteria:
- Patients with newly diagnosed PVNS with, at least, one measurable site of disease on
MRI.
- Patients expected to get surgery.
- 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.
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8
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