Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2009-012380-34-GB |
Date of registration:
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24/09/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study of the safety and efficacy of CNTO328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease
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Scientific title:
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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:
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18/05/2010 |
Target sample size:
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78 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012380-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Canada
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China
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Egypt
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France
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Germany
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Hong Kong
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Hungary
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India
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Israel
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Korea, Republic of
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Malaysia
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Netherlands
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New Zealand
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Norway
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Russian Federation
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Singapore
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Key inclusion & exclusion criteria
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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: - 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
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Health Condition(s) or Problem(s) studied
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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)
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Intervention(s)
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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 and 400- Pharmaceutical form of the placebo: Powder for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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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
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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.
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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).
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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.
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Secondary Outcome(s)
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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.
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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
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Secondary ID(s)
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CNTO328MCD2001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Ethics review
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Status: Approved
Approval date:
Contact:
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