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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00385827
Recruitment Status : Terminated (Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy.)
First Posted : October 11, 2006
Results First Posted : June 12, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer, Prostate
Interventions Drug: Mitoxantrone
Drug: Siltuximab
Drug: Prednisone
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Period Title: Part 1
Started 9 0 0
Treated 9 0 0
Completed 0 0 0
Not Completed 9 0 0
Reason Not Completed
Adverse Event             1             0             0
Death             2             0             0
Lack of Efficacy             5             0             0
Other             1             0             0
Period Title: Part 2
Started 0 49 48
Treated 0 47 46
Completed 0 16 0
Not Completed 0 33 48
Reason Not Completed
Adverse Event             0             6             10
Death             0             0             2
Lack of Efficacy             0             14             13
Randomized but not treated             0             2             2
Other             0             11             21
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab Total
Hide Arm/Group Description Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. Total of all reporting groups
Overall Number of Baseline Participants 9 49 48 106
Hide Baseline Analysis Population Description
Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 49 participants 48 participants 106 participants
69.4  (7.89) 67.8  (7.83) 67.9  (9.28) 68  (8.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 49 participants 48 participants 106 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
49
 100.0%
48
 100.0%
106
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 49 participants 48 participants 106 participants
AUSTRIA 0 1 2 3
BELGIUM 0 6 6 12
FRANCE 0 15 12 27
GERMANY 0 4 5 9
SPAIN 0 7 4 11
UNITED KINGDOM 0 5 6 11
UNITED STATES 9 11 13 33
1.Primary Outcome
Title Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame Baseline up to 12 weeks after last dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population in Part 1 included all participants who received at least one dose of study drug.
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
AEs 9
SAEs 5
2.Primary Outcome
Title Part 2: Progression Free Survival (PFS)
Hide Description The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.
Time Frame Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population in Part 2 included all randomized participants.
Arm/Group Title Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 49 48
Median (95% Confidence Interval)
Unit of Measure: days
228.0
(155.0 to 303.0)
97.0
(84.0 to 179.0)
3.Secondary Outcome
Title Time to Clinical Deterioration (TtCD)
Hide Description The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.
Time Frame Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 9 49 48
Median (95% Confidence Interval)
Unit of Measure: days
199.0 [1] 
(107.0 to NA)
298.0
(128.0 to 342.0)
183.0
(142.0 to 274.0)
[1]
Upper limit of the confidence interval was not reachable as data was not matured at the time of the analysis, due to early study termination.
4.Secondary Outcome
Title Number of Participants With Palliative Response
Hide Description Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.
Time Frame Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Prostate Specific Antigen (PSA) Response
Hide Description The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.
Time Frame Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 9 46 45
Measure Type: Number
Unit of Measure: participants
4 12 7
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.
Time Frame Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description:
Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
Overall Number of Participants Analyzed 9 49 48
Median (95% Confidence Interval)
Unit of Measure: days
368.0 [1] 
(214.0 to NA)
394.0
(311.0 to 438.0)
311.0 [1] 
(226.0 to NA)
[1]
Upper limit of the confidence interval was not reachable as data was not matured at the time of the analysis, due to early study termination.
Time Frame Baseline up to 12 weeks after last dose administration
Adverse Event Reporting Description Safety population in Part 1 and 2 included all participants who received at least one dose of study drug.
 
Arm/Group Title Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Hide Arm/Group Description Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
All-Cause Mortality
Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   18/47 (38.30%)   18/46 (39.13%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/9 (0.00%)  0/47 (0.00%)  2/46 (4.35%) 
Febrile Neutropenia * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Haemolysis * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Leukocytosis * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Leukopenia * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Neutropenia * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Thrombocytopenia * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Cardiac disorders       
Cardiac Failure * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Supraventricular Tachycardia * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Eye disorders       
Diplopia * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Gastrointestinal disorders       
Anal Fissure * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Constipation * 1  0/9 (0.00%)  0/47 (0.00%)  2/46 (4.35%) 
Diarrhoea * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Ileus * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Inguinal Hernia * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Nausea * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Vomiting * 1  0/9 (0.00%)  1/47 (2.13%)  3/46 (6.52%) 
General disorders       
Catheter Site Haemorrhage * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Chest Pain * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Disease Progression * 1  2/9 (22.22%)  3/47 (6.38%)  6/46 (13.04%) 
Fatigue * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
General Physical Health Deterioration * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Pyrexia * 1  1/9 (11.11%)  2/47 (4.26%)  0/46 (0.00%) 
Infections and infestations       
Cellulitis * 1  1/9 (11.11%)  0/47 (0.00%)  2/46 (4.35%) 
Gastroenteritis * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Pneumonia * 1  0/9 (0.00%)  2/47 (4.26%)  1/46 (2.17%) 
Sepsis * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Septic Shock * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Urinary Tract Infection * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Urosepsis * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Injury, poisoning and procedural complications       
Femoral Neck Fracture * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Investigations       
Fibrinolysis * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Fibrinolysis Increased * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
International Normalised Ratio Decreased * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Weight Decreased * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Diabetes Mellitus Inadequate Control * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Failure to Thrive * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  0/9 (0.00%)  2/47 (4.26%)  1/46 (2.17%) 
Bone Pain * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Muscular Weakness * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Musculoskeletal Pain * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Pain in Extremity * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Pathological Fracture * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate Cancer Metastatic * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Nervous system disorders       
Cerebral Haemorrhage * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Cerebrovascular Accident * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Facial Palsy * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Spinal Cord Compression * 1  0/9 (0.00%)  0/47 (0.00%)  2/46 (4.35%) 
Syncope * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Psychiatric disorders       
Confusional State * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Renal and urinary disorders       
Renal Failure * 1  0/9 (0.00%)  1/47 (2.13%)  1/46 (2.17%) 
Renal Impairment * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Ureteric Obstruction * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Pleural Haemorrhage * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Pulmonary Embolism * 1  0/9 (0.00%)  2/47 (4.26%)  0/46 (0.00%) 
Vascular disorders       
Haematoma * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Haemorrhage * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Hypertensive Crisis * 1  0/9 (0.00%)  0/47 (0.00%)  1/46 (2.17%) 
Hypotension * 1  1/9 (11.11%)  0/47 (0.00%)  3/46 (6.52%) 
Venous Thrombosis * 1  0/9 (0.00%)  1/47 (2.13%)  0/46 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Mitoxantrone + Prednisone + Siltuximab Part 2: Mitoxantrone + Prednisone Part 2: Mitoxantrone + Prednisone + Siltuximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   42/47 (89.36%)   46/46 (100.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  6/9 (66.67%)  11/47 (23.40%)  4/46 (8.70%) 
Leukopenia * 1  7/9 (77.78%)  2/47 (4.26%)  10/46 (21.74%) 
Lymphopenia * 1  0/9 (0.00%)  3/47 (6.38%)  2/46 (4.35%) 
Neutropenia * 1  9/9 (100.00%)  14/47 (29.79%)  29/46 (63.04%) 
Thrombocytopenia * 1  6/9 (66.67%)  3/47 (6.38%)  11/46 (23.91%) 
Cardiac disorders       
Left Ventricular Dysfunction * 1  0/9 (0.00%)  3/47 (6.38%)  1/46 (2.17%) 
Sinus Tachycardia * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  0/9 (0.00%)  0/47 (0.00%)  4/46 (8.70%) 
Eye disorders       
Blindness * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Vision Blurred * 1  1/9 (11.11%)  0/47 (0.00%)  2/46 (4.35%) 
Visual Impairment * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Gastrointestinal disorders       
Abdominal Pain * 1  1/9 (11.11%)  2/47 (4.26%)  2/46 (4.35%) 
Abdominal Pain Upper * 1  0/9 (0.00%)  4/47 (8.51%)  2/46 (4.35%) 
Ascites * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Constipation * 1  1/9 (11.11%)  17/47 (36.17%)  8/46 (17.39%) 
Diarrhoea * 1  3/9 (33.33%)  5/47 (10.64%)  11/46 (23.91%) 
Gingival Bleeding * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Gingival Pain * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Nausea * 1  4/9 (44.44%)  7/47 (14.89%)  18/46 (39.13%) 
Stomatitis * 1  1/9 (11.11%)  2/47 (4.26%)  2/46 (4.35%) 
Vomiting * 1  3/9 (33.33%)  2/47 (4.26%)  6/46 (13.04%) 
General disorders       
Asthenia * 1  1/9 (11.11%)  9/47 (19.15%)  12/46 (26.09%) 
Chest Pain * 1  1/9 (11.11%)  0/47 (0.00%)  4/46 (8.70%) 
Chills * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Fatigue * 1  4/9 (44.44%)  10/47 (21.28%)  14/46 (30.43%) 
Oedema Peripheral * 1  1/9 (11.11%)  0/47 (0.00%)  5/46 (10.87%) 
Temperature Intolerance * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Hepatobiliary disorders       
Hepatic Function Abnormal * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Infections and infestations       
Cellulitis * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Localised Infection * 1  2/9 (22.22%)  1/47 (2.13%)  3/46 (6.52%) 
Rhinitis * 1  3/9 (33.33%)  0/47 (0.00%)  0/46 (0.00%) 
Staphylococcal Infection * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Upper Respiratory Tract Infection * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Urinary Tract Infection * 1  0/9 (0.00%)  4/47 (8.51%)  1/46 (2.17%) 
Injury, poisoning and procedural complications       
Skin Laceration * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Investigations       
Ejection Fraction Decreased * 1  0/9 (0.00%)  2/47 (4.26%)  3/46 (6.52%) 
International Normalised Ratio Increased * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Low Density Lipoprotein Increased * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Weight Decreased * 1  3/9 (33.33%)  1/47 (2.13%)  5/46 (10.87%) 
Metabolism and nutrition disorders       
Anorexia * 1  4/9 (44.44%)  3/47 (6.38%)  1/46 (2.17%) 
Dehydration * 1  2/9 (22.22%)  0/47 (0.00%)  0/46 (0.00%) 
Enzyme Abnormality * 1  2/9 (22.22%)  0/47 (0.00%)  1/46 (2.17%) 
Hypercholesterolaemia * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Hyperglycaemia * 1  4/9 (44.44%)  0/47 (0.00%)  1/46 (2.17%) 
Hypertriglyceridaemia * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Hypocalcaemia * 1  2/9 (22.22%)  1/47 (2.13%)  1/46 (2.17%) 
Hypokalaemia * 1  2/9 (22.22%)  0/47 (0.00%)  0/46 (0.00%) 
Hypomagnesaemia * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Hyponatraemia * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Hypophosphataemia * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Vitamin B12 Deficiency * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/9 (11.11%)  1/47 (2.13%)  5/46 (10.87%) 
Back Pain * 1  3/9 (33.33%)  8/47 (17.02%)  4/46 (8.70%) 
Bone Pain * 1  1/9 (11.11%)  3/47 (6.38%)  7/46 (15.22%) 
Groin Pain * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Muscle Spasms * 1  0/9 (0.00%)  5/47 (10.64%)  3/46 (6.52%) 
Muscular Weakness * 1  1/9 (11.11%)  0/47 (0.00%)  2/46 (4.35%) 
Musculoskeletal Chest Pain * 1  0/9 (0.00%)  3/47 (6.38%)  0/46 (0.00%) 
Musculoskeletal Pain * 1  0/9 (0.00%)  4/47 (8.51%)  7/46 (15.22%) 
Pain in Extremity * 1  0/9 (0.00%)  4/47 (8.51%)  6/46 (13.04%) 
Nervous system disorders       
Cerebral Ischaemia * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Dizziness * 1  3/9 (33.33%)  2/47 (4.26%)  3/46 (6.52%) 
Dysgeusia * 1  1/9 (11.11%)  1/47 (2.13%)  3/46 (6.52%) 
Headache * 1  1/9 (11.11%)  1/47 (2.13%)  3/46 (6.52%) 
Hyperaesthesia * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Paraesthesia * 1  0/9 (0.00%)  2/47 (4.26%)  3/46 (6.52%) 
Peripheral Motor Neuropathy * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Peripheral Sensory Neuropathy * 1  1/9 (11.11%)  1/47 (2.13%)  2/46 (4.35%) 
Psychiatric disorders       
Anxiety * 1  1/9 (11.11%)  2/47 (4.26%)  2/46 (4.35%) 
Insomnia * 1  1/9 (11.11%)  1/47 (2.13%)  1/46 (2.17%) 
Renal and urinary disorders       
Haematuria * 1  1/9 (11.11%)  2/47 (4.26%)  0/46 (0.00%) 
Renal Failure * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Renal Impairment * 1  0/9 (0.00%)  3/47 (6.38%)  1/46 (2.17%) 
Urinary Bladder Haemorrhage * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/9 (11.11%)  2/47 (4.26%)  4/46 (8.70%) 
Dyspnoea * 1  1/9 (11.11%)  2/47 (4.26%)  8/46 (17.39%) 
Dyspnoea Exertional * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Epistaxis * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Pleural Effusion * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Postnasal Drip * 1  2/9 (22.22%)  0/47 (0.00%)  0/46 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  3/9 (33.33%)  1/47 (2.13%)  3/46 (6.52%) 
Nail Disorder * 1  0/9 (0.00%)  2/47 (4.26%)  4/46 (8.70%) 
Purpura * 1  1/9 (11.11%)  0/47 (0.00%)  0/46 (0.00%) 
Rash * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Skin Disorder * 1  1/9 (11.11%)  1/47 (2.13%)  0/46 (0.00%) 
Vascular disorders       
Flushing * 1  1/9 (11.11%)  0/47 (0.00%)  1/46 (2.17%) 
Hot Flush * 1  0/9 (0.00%)  1/47 (2.13%)  4/46 (8.70%) 
Hypertension * 1  1/9 (11.11%)  0/47 (0.00%)  2/46 (4.35%) 
Hypotension * 1  3/9 (33.33%)  3/47 (6.38%)  0/46 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Results of few secondary endpoints were not reported as the study was terminated early due to the premature suspension and subsequent halting of study enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director
Organization: Janssen Research & Development
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00385827     History of Changes
Other Study ID Numbers: CR012346
C0328T07
2006-001671-38 ( EudraCT Number )
First Submitted: October 6, 2006
First Posted: October 11, 2006
Results First Submitted: May 13, 2014
Results First Posted: June 12, 2014
Last Update Posted: August 20, 2014