MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01643850
First received: March 8, 2012
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pigmented Villonodular Synovitis PVNS |
Drug: MCS110 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in pigmented villonodular synovitis (PVNS) tumor size [ Time Frame: week 4 ] [ Designated as safety issue: No ]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)
- Number of participants with adverse events [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]adverse events assessment
Secondary Outcome Measures:
- Pharmacokinetics of MCS110 and best estimates for key PK parameters including [not limited to] area under the serum concentration-time curve (AUC), clearance (CL), apparent volume of distribution (V), mean residence time (MRT), half-lives (T1/2), etc [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: No ]Pharmacokinetic characterization of a single dose of MCS110
- Evaluation of macrophage-colony stimulating factor (MCSF) plasma concentrations over time [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: No ]Pharmacodynamic characterization of a single dose of MCS110
- Change in Serum C-terminal Type 1 collagen peptide concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: No ]Pharmacodynamic characterization of a single dose of MCS110
- Number of CD14+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: Yes ]Pharmacodynamic characterization of a single dose of MCS110
- Number of CD14+ CD16+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: Yes ]Pharmacodynamic characterization of a single dose of MCS110
- Change in Joint range of motion score [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: No ]Assessment of the duration of the clinical response
- Change in Western Ontario-McMaster Arthritis (WOMAC) score [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: No ]Assessment of the duration of the clinical response
- Change in serum anti-MCS110 antibody concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ] [ Designated as safety issue: Yes ]Assessment of the immunogenicity
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MCS110
Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion.
|
Drug: MCS110
Patients will receive the single dose of MCS110 (10mg/kg) on day 1
|
| Placebo Comparator: Placebo |
Drug: Placebo
Participants will receive a single dose of NaCl on day 1
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643850
Contacts
| Contact: Novartis Pharmaceuticals | 862-778-8300 |
Locations
| United States, California | |
| Novartis Investigative Site | Not yet recruiting |
| San Diego, California, United States, 92103-8894 | |
| United States, District of Columbia | |
| Novartis Investigative Site | Not yet recruiting |
| Washington, District of Columbia, United States, 20011 | |
| United States, Florida | |
| Novartis Investigative Site | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Novartis Investigative Site | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| United States, Minnesota | |
| Novartis Investigative Site | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
Publications:
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01643850 History of Changes |
| Other Study ID Numbers: | CMCS110X2201, 2011-002951-32 |
| Study First Received: | March 8, 2012 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Pigmented Villonodular Synovitis PVNS MCS110 |
Additional relevant MeSH terms:
|
Synovitis Synovitis, Pigmented Villonodular Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013