MedPath

Siltuximab

Generic Name
Siltuximab
Brand Names
Sylvant
Drug Type
Biotech
CAS Number
541502-14-1
Unique Ingredient Identifier
T4H8FMA7IM
Background

Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.

Indication

Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.

Associated Conditions
Castleman Disease

A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

Phase 1
Terminated
Conditions
Multiple Myeloma
Interventions
First Posted Date
2011-03-07
Last Posted Date
2014-05-19
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
9
Registration Number
NCT01309412

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

Phase 2
Completed
Conditions
Multicentric Castleman's Disease
Interventions
Drug: Placebo
Drug: Best Supportive Care (BSC)
First Posted Date
2009-12-02
Last Posted Date
2018-03-21
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
79
Registration Number
NCT01024036

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-06-02
Last Posted Date
2014-11-18
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
118
Registration Number
NCT00911859

A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

Phase 1
Completed
Conditions
Lymphoma, Non-Hodgkin
Multiple Myeloma
Giant Lymph Node Hyperplasia
Interventions
First Posted Date
2006-12-18
Last Posted Date
2014-07-01
Lead Sponsor
Centocor, Inc.
Target Recruit Count
67
Registration Number
NCT00412321

A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Phase 1
Completed
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2006-11-22
Last Posted Date
2014-05-26
Lead Sponsor
Centocor, Inc.
Target Recruit Count
40
Registration Number
NCT00401765

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Phase 2
Terminated
Conditions
Cancer, Prostate
Interventions
First Posted Date
2006-10-11
Last Posted Date
2014-08-20
Lead Sponsor
Centocor, Inc.
Target Recruit Count
106
Registration Number
NCT00385827

A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma

Phase 1
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2005-12-14
Last Posted Date
2014-07-03
Lead Sponsor
Centocor, Inc.
Target Recruit Count
68
Registration Number
NCT00265135
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