A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's Disease

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2010-022837-27-BE
• Date of registration: 23/07/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's Disease
• Scientific title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease
• Date of first enrolment: 17/12/2012
• Target sample size: 75
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022837-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Israel, Korea, Republic of, New Zealand, Norway, Singapore, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
- Have multicentric Castleman's disease
- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
- Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
- Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Known unmanageable allergies, hypersensitivity, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multicentric Castleman's Disease
MedDRA version: 17.0 Level: PT Classification code 10050251 Term: Castleman's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: CNTO328
Product Code: CNTO328
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 541502-14-1
Current Sponsor code: CNTO328
Other descriptive name: SILTUXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective is to evaluate the long-term safety of siltuximab in subjects with MCD.

Timepoint(s) of evaluation of this end point: Up to 6 years

Primary end point(s): Proportion of patients for adverse events as a measure of safety

Secondary Objective: - To determine the proportion of previously responding subjects who maintain disease control
- To determine the proportion of siltuximab-naive subjects who experience disease control
- To describe the duration of disease control and survival
- To assess reliability of a multicentric Castleman’s disease symptom scale (MCDSS)
- To evaluate IL-6 levels
- To assess formation of antibodies to siltuximab (immunogenicity) after long-term treatment in the MCD population

Secondary Outcome(s)

Secondary end point(s): - Proportion of multicentric Castleman's disease (MCD) patients evaluated for pharmacodynamic biomarkers
- Proportion of previously responding MCD patients and siltuximab-naive patients who maintain disease control
- Duration of MCD disease control and survival
- Proportion of patients for Multicentric Castleman's Disease Symptom Scale (MCDSS) as a measure of the severity of symptoms
- Assessment of glycoform clearance analysis
- Assessment of in vivo protein degradation analysis

Timepoint(s) of evaluation of this end point: Up to 6 Years

Secondary ID(s)

CNTO328MCD2002

Source(s) of Monetary Support

Janssen Research & Development, LLC