Trial record 1 of 1 for:    MCD2001
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A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01024036
First received: November 30, 2009
Last updated: January 20, 2014
Last verified: January 2014

November 30, 2009
January 20, 2014
March 2010
March 2013   (final data collection date for primary outcome measure)
Number of patients that achieve a tumor and symptomatic response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
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.
Durable tumor and symptomatic response. [ Time Frame: 48 weeks after the last patient begins study treatment. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01024036 on ClinicalTrials.gov Archive Site
  • Duration of tumor and symptomatic response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure.
  • Number of patients with tumor response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Tumor response is based on the assessment of index lesions (measurable) and nonindex lesions (non measurable).
  • Duration of Tumor Response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as time from first documentation of tumor response (CR or PR) to tumor progression.
  • Time to Treatment Failure [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as the time from randomization to treatment failure.
  • Maximum change from baseline in hemoglobin value [ Time Frame: Baseline up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Change in hemoglobin will be calculated as maximum change from baseline (in hemoglobin value) in the absence of transfusion.
  • Number of patients that discontinued corticosteroid therapy [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    These are the number of patients who are able to discontinue corticosteroids, if they were corticosteroid dependent at study entry.
  • Change from baseline in relevant patient reported outcome scales [ Time Frame: Baseline up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Changes versus baseline will be compared between cohorts.
  • Maximum observed serum concentration of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Maximum observed serum concentration of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.
  • Minimum observed serum concentration of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Minimum observed serum concentration of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.
  • Area under the serum concentration versus time curve of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Area under the serum concentration versus time curve of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.
  • Half-life of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Half-life of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.
  • Volume of distribution of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Volume of distribution of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.
  • Number of patients with antibodies to CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Antibodies to CNTO 328 will be detected using a validated immunoassay. All samples collected for detection of antibodies to CNTO 328 will also be evaluated for CNTO 328 serum concentration to interpret antibody response data.
  • Number of patients with adverse events [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics (the way the body absorbs, distributes and gets rid of a drug) of CNTO 328 among MCD patients [ Time Frame: 48 weeks after last patient begins study treatment ] [ Designated as safety issue: No ]
  • Immune response [ Time Frame: 48 weeks after last patient begins study treatment ] [ Designated as safety issue: No ]
  • Clinical efficacy [ Time Frame: 48 weeks after last patient begins study treatment ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: 48 weeks after last patient begins study treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multicentric Castleman's Disease
  • Drug: CNTO 328
    Type=exact number, unit=mg/kg, number=11, form=injection, route=intravenous. CNTO 328 will be administered every 3 weeks.
  • Drug: Placebo
    Form=injection, route=intravenous. Placebo will be administered every 3 weeks.
  • Experimental: CNTO 328
    CNTO 328 11 mg/kg administered intravenously every 3 weeks.
    Intervention: Drug: CNTO 328
  • Placebo Comparator: Placebo
    Placebo administered intravenously every 3 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
February 2017
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT01024036
CR016705, CNTO328MCD2001, 2009-012380-34
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP