Trial · NCT01643850
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
NCT01643850, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS). Trials, record NCT01643850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01643850
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
- NCT number
- NCT01643850
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Pigmented Villonodular Synovitis, PVNS, Giant Cell Tumor of the Tendon Sheath, GCCTS, Tenosynovial Giant Cell Tumor Localized or Diffused Type, GCTS
- Interventions
- MCS110, Placebo
- First posted
- 2012-07-18
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2011-002951-32
- Results first posted
- 2020-02-27
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Week 4 | 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 set is called "ABC4". |
| Primary | Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Week 4 | To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single 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 set is called "ABC4". |
| Primary | Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | Up to 8 weeks post last dose | Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 \& 10 mg/kg or 5 \& 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\] |
| Primary | Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | Up to 8 weeks post last dose | To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\]. |
| Primary | Number of Participants With Adverse Events | Approximately 2 years | Overall incidence of Adverse Events |
| Secondary | Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC). |
| Secondary | Pharmacokinetics of MCS110 Maximum Concentration (Cmax) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax) |
| Secondary | Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax) |
| Secondary | Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time | Baseline, Day 1, Day 85, Day 169 | Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time |
| Secondary | Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I). | Baseline, Week 4, Week 24, Week 104 | Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Week 4 | Pharmacodynamic Analysis Set | mm3 | MEAN |
| PRIMARY | Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Week 4 | Pharmacodynamic Analysis Set | Percentage | MEAN |
| PRIMARY | Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | Up to 8 weeks post last dose | Pharmacodynamic Analysis Set | mm3 | MEAN |
| PRIMARY | Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | Up to 8 weeks post last dose | Pharmacodynamic Analysis Set | Percentage | MEAN |
| PRIMARY | Number of Participants With Adverse Events | Approximately 2 years | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic Analysis Set | h* ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of MCS110 Maximum Concentration (Cmax) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic Analysis Set | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax) | Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) | Pharmacokinetic Analysis Set | hour (h) | MEDIAN |
| SECONDARY | Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time | Baseline, Day 1, Day 85, Day 169 | Pharmacokinetic Analysis Set | pg/mL | MEAN |
| SECONDARY | Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I). | Baseline, Week 4, Week 24, Week 104 | Pharmacodynamic analysis | ng/mL | MEDIAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group477
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Placebo (PART ABC4) | -4222.8 | Standard Deviation 6284.56 | mm3 | |
| Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 3 mg/kg (PART ABC4) | -668.5 | Standard Deviation 18751.44 | mm3 | |
| Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 5 mg/kg (PART ABC4) | -9998.4 | Standard Deviation 15628.40 | mm3 | |
| Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 10 mg/kg (PART ABC4) | -38002.1 | Standard Deviation 57314.73 | mm3 | |
| Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | Placebo (PART ABC4) | -7.7 | Standard Deviation 5.10 | Percentage | |
| Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 3 mg/kg (PART ABC4) | -7.4 | Standard Deviation 13.21 | Percentage | |
| Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 5 mg/kg (PART ABC4) | -24.8 | Standard Deviation 23.42 | Percentage | |
| Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size | MCS110 10 mg/kg (PART ABC4) | -32.6 | Standard Deviation 16.61 | Percentage | |
| Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | MCS110 3 mg/kg (PART C) | -2450.3 | Standard Deviation 2721.24 | mm3 | |
| Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size | MCS110 5 mg/kg (PART C) | -29164.3 | Standard Deviation 23286.18 | mm3 |
1 to 10 of 477Source ClinicalTrials.gov
See all 477 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MCS110 10 mg/kg (PART A) | 5 | |
| Overall Study | STARTED | Placebo (PART A) | 2 | |
| Overall Study | STARTED | MCS110 10 mg/kg (PART B) | 8 | |
| Overall Study | STARTED | Placebo/10mg/kg (PART B) | 3 | |
| Overall Study | STARTED | MCS110 3 mg/kg (Part C) | 3 | |
| Overall Study | STARTED | MCS110 5 mg/kg (Part C) | 3 | |
| Overall Study | STARTED | MCS110 10 mg/kg (Part C) | 4 | |
| Overall Study | STARTED | MCS110 3 mg/kg & MCS110 10mg/kg (Part C) | 4 | |
| Overall Study | STARTED | MCS110 5 mg/kg & MCS110 10mg/kg (PART C) | 4 | |
| Overall Study | COMPLETED | MCS110 10 mg/kg (PART A) | 5 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events966
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCS110 10 mg/kg (PART A) | 0 | 5 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo (PART A) | 0 | 2 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCS110 10mg/kg (PART B) | 0 | 11 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo/10mg/kg (PART B) | 0 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCS110 3mg/kg (PART C) | 1 | 7 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCS110 5mg/kg (PART C) | 0 | 7 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCS110 10mg/kg (PART C) | 1 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | MCS110 10 mg/kg (PART A) | 0 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo (PART A) | 0 | 2 | |
| other | Leukopenia | Blood and lymphatic system disorders | MCS110 10mg/kg (PART B) | 1 | 11 |
1 to 10 of 966Source ClinicalTrials.gov
See all 966 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MCS110 10 mg/kg (PART A) | 0 | 5 |
| Total, all-cause mortality | Placebo (PART A) | 0 | 2 |
| Total, all-cause mortality | MCS110 10mg/kg (PART B) | 0 | 11 |
| Total, all-cause mortality | Placebo/10mg/kg (PART B) | 0 | 3 |
| Total, all-cause mortality | MCS110 3mg/kg (PART C) | 0 | 7 |
| Total, all-cause mortality | MCS110 5mg/kg (PART C) | 0 | 7 |
| Total, all-cause mortality | MCS110 10mg/kg (PART C) | 0 | 12 |
| Total, other adverse events | MCS110 10 mg/kg (PART A) | 3 | 5 |
| Total, other adverse events | Placebo (PART A) | 1 | 2 |
| Total, other adverse events | MCS110 10mg/kg (PART B) | 11 | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18296418 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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