A study of the safety and efficacy of CNTO 328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease

• Register: EUCTR
• Last refreshed on: 26 November 2013
• Main ID: EUCTR2009-012380-34-DE
• Date of registration: 15/10/2009
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A study of the safety and efficacy of CNTO 328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease
• Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s Disease
• Date of first enrolment: 27/01/2010
• Target sample size: 75
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012380-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Belgium, France, Germany, Hungary, Netherlands, Spain, United Kingdom

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:
Measurable and symptomatic Multicentric Castleman's Disease
- Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment
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 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
- Human Immunodeficiency Virus or Human Herpes Virus-8 positive
- Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease - Previous history of lymphoma
- Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years - Concurrent medical condition or disease that may interfere with study participation
- Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies


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

Health Condition(s) or Problem(s) studied

Multicentric Castleman's disease
MedDRA version: 14.1 Level: PT Classification code 10050251 Term: Castleman's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: CNTO328
Product Code: CNTO328
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: CNTO 328
Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: CNTO328
Product Code: CNTO328
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: CNTO 328
Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Primary Outcome(s)

Main Objective: The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superior to BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjects with multicentric Castleman’s disease (MCD).

Primary end point(s): The primary efficacy endpoint will be objective tumor response (CR + PR) modified to allow assessment of measurable cutaneous lesions, as measured by Cheson criteria (Cheson et al, 2007; positron-emission tomography [PET] scan data, if obtained, will not be taken into account).

Timepoint(s) of evaluation of this end point: Treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last subject starts study treatment, whichever occurs earlier.

Secondary Objective: The secondary objectives of this study are:
• To demonstrate additional measures of efficacy (duration of tumor response; time to treatment failure; change in hemoglobin levels; ability to discontinue corticosteroids; and improvement in fatigue, physical function, and other disease-related symptoms)
• To study the safety of prolonged dosing
• To determine the pharmacokinetics of CNTO 328 among subjects with MCD
• To determine a baseline hepcidin value predictive of a = 2 g/dL increase in hemoglobin

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last subject starts study treatment, whichever occurs earlier.

Secondary end point(s): - Duration of tumor and symptomatic response (whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions)
- Tumor response
- Duration of tumor response (whenever possible, tumor progression documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions)
- Time to treatment failure
- Maximum change from baseline in hemoglobin in the absence of transfusion
- Proportion of subjects who are able to discontinue corticosteroids

Secondary ID(s)

2009-012380-34-GB

CNTO328MCD2001

Source(s) of Monetary Support

Janssen Research & Development