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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multicentric Castleman's Disease

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Trial Information

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


This is a multicenter (study conducted at multiple sites), randomized (the study medication
is assigned by chance), double blind (neither investigator nor the participant knows the
treatment that the participant receives), placebo controlled (an inactive substance that is
compared with the study medication to test whether the study medication has a real effect in
clinical study), study to assess the efficacy and safety of CNTO 328 plus BSC compared with
BSC in patients with symptomatic Multicentric Castleman's Disease. The study mainly consists
of 3 phases, including: the screening phase (majority of assessments performed within 28
days of first dose), the treatment phase, and the follow up phase. In the treatment phase,
approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment
groups, ie, Treatment Group A: Placebo + BSC, or Treatment Group B: CNTO 328 + BSC. The
follow up phase will be 3 months after last dose of study medication and the survival will
be followed up until the study ends. Safety evaluations for adverse events, clinical
laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical
examination will be monitored throughout the study. The total study duration will be 5 years
after the last patient starts study medication.


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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of patients that achieve a tumor and symptomatic response

Outcome Description:

Tumor and symptomatic response may be either a complete response (CR) or a partial response (PR). CR is defined as a complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to Multicentric Castleman's disease, sustained for at least 18 weeks. PR is defined as a greater than or equal to 50% decrease in sum of the product of the diameters (SPD) of index lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure, sustained for at least 18 weeks.

Outcome Time Frame:

Up to 48 weeks after the last patient begins study treatment

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR016705

NCT ID:

NCT01024036

Start Date:

March 2010

Completion Date:

February 2017

Related Keywords:

  • Multicentric Castleman's Disease
  • Multicentric Castleman's Disease
  • MCD
  • CNTO 328
  • Best Supportive Care
  • Tumor
  • Symptomatic response
  • Pharmacokinetics
  • Interleukin-6
  • IL6
  • Giant Lymph Node Hyperplasia

Name

Location
Alexandria, Minnesota  56308
Fountain Valley, California  92708
Miami, Florida  33176
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Little Rock, Arkansas  72205-7199
Boston, Massachusetts  
Charlotte, North Carolina  
Charleston, South Carolina  
Salt Lake City, Utah  84112