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)
Conditions
Interventions
Product Name: CNTO328
Product Code: CNTO328
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint will be durable tumor and symptomatic response. For definitions, see Section 9.2.2 of the protocol.;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.;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 durable tumor and symptomatic response among subjects with multicentric Castleman’s disease (MCD).; Secondary Objective: The secondary objectives of this study are: • To demonstrate additional measures of efficacy (tumor response; duration of 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
| Measure | Time frame |
|---|---|
| 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 ;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. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Korea, Republic of, Malaysia, Netherlands, New Zealand, Norway, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International N.V.
Outcome results
None listed