A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Multicentric Castleman's Disease

In brief

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

Key facts

Study ID

NCT01024036

Run by

Janssen Research & Development, LLC

People needed

79

Starts

2010-03-18

Expected to finish

2017-02-24

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Tampa, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Lansing, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Greenville, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — East Melbourne, Australia
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Brasília, Brazil
• Study site — Porto Alegre, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Toronto, Canada
• Study site — Beijing, China
• Study site — Chengdu, China
• Study site — Guangzhou, China
• Study site — Hangzhou, China
• Study site — Shanghai, China
• Study site — Cairo, Egypt
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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