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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pigmented Villonodular Synovitis, PVNS

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Trial Information

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)

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in pigmented villonodular synovitis (PVNS) tumor size

Outcome Description:

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)

Outcome Time Frame:

week 4

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CMCS110X2201

NCT ID:

NCT01643850

Start Date:

April 2012

Completion Date:

June 2013

Related Keywords:

  • Pigmented Villonodular Synovitis
  • PVNS
  • Pigmented Villonodular Synovitis
  • PVNS
  • MCS110
  • Synovitis
  • Synovitis, Pigmented Villonodular

Name

Location

Novartis Investigative SiteChicago, Illinois  60612
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteWashington, District of Columbia  20007-2197