Trials / Completed
CompletedNCT01643850
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Pigmented Villonodular Synovitis
- PVNS
- Giant Cell Tumor of the Tendon Sheath
- GCCTS
- Tenosynovial Giant Cell Tumor Localized or Diffused Type
- GCTS
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MCS110 | 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. |
| DRUG | Placebo | Participants will receive a single dose of NaCl on day 1 through intravenous infusion. |
Timeline
- Start date
- 2012-04-23
- Primary completion
- 2017-12-07
- Completion
- 2018-12-21
- First posted
- 2012-07-18
- Last updated
- 2021-01-05
- Results posted
- 2020-02-27
Locations
8 sites across 2 countries: United States, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01643850. Inclusion in this directory is not an endorsement.