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NCT01643850 · ClinicalTrials.gov registry record · Phase 2
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01643850: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01643850 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01643850, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data
Interventions
- DRUG Placebo
- DRUG MCS110
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-04-23 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
What the finished NCT01643850 record still lists
NCT01643850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01643850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01643850 about?
NCT01643850 is a clinical study titled "MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)". 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 t...
What is the current status of trial NCT01643850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-04-23. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT01643850?
The interventions under investigation include: Placebo (DRUG), MCS110 (DRUG).
Who is sponsoring clinical trial NCT01643850?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01643850's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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