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XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)

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: NCT00417079
Recruitment Status : Completed
First Posted : December 29, 2006
Results First Posted : December 23, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Prostatic Neoplasms
Interventions Drug: cabazitaxel (XRP6258) (RPR116258)
Drug: mitoxantrone
Drug: prednisone
Enrollment 755
Recruitment Details Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009.
Pre-assignment Details

165 patients signed informed consent but were not randomized and considered as screen failure.

Intention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel).

Safety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Period Title: Overall Study
Started 377 [1] 378 [1]
Completed 46 [1] 105 [1]
Not Completed 331 273
Reason Not Completed
Disease progression             267             180
Adverse Event             32             67
Non-compliance to protocol             0             1
Lost to Follow-up             2             0
Withdrawal by Subject             17             8
Not treated             6             7
Screened failure             2             1
Investigator's decision             1             4
Non-confirmed Disease progression             1             1
Clinical deterioration             1             0
Screening error             2             1
Withdrawal by subject's family             0             1
Patient unable to come to the clinic             0             1
abnormal liver function tests             0             1
[1]
Randomized patients
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone Total
Hide Arm/Group Description mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily Total of all reporting groups
Overall Number of Baseline Participants 377 378 755
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 377 participants 378 participants 755 participants
67.0
(47 to 89)
68.0
(46 to 92)
67
(46 to 92)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 377 participants 378 participants 755 participants
377 378 755
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 377 participants 378 participants 755 participants
United States 106 97 203
Taiwan 4 7 11
Slovakia 1 1 2
Spain 10 9 19
Chile 9 12 21
Russian Federation 6 4 10
Italy 17 18 35
India 11 9 20
France 44 46 90
Denmark 19 26 45
South Africa 7 9 16
Netherlands 8 9 17
Korea, Republic of 8 7 15
Finland 4 1 5
Turkey 17 19 36
United Kingdom 17 20 37
Hungary 8 7 15
Czech Republic 10 12 22
Mexico 2 3 5
Canada 16 16 32
Argentina 7 3 10
Brazil 7 4 11
Belgium 16 15 31
Singapore 6 3 9
Germany 6 11 17
Sweden 11 10 21
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 377 participants 378 participants 755 participants
0 - Fully Active 120 141 261
1 - Ambulatory, Restricted Activity 224 209 433
2 - Ambulatory, No Work Activities 33 28 61
Prostatic Specific Antigen PSA  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 377 participants 378 participants 755 participants
127.5
(2 to 11220)
143.9
(2 to 7842)
135.00
(2 to 11220)
Measurable disease   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 377 participants 378 participants 755 participants
Measurable disease 204 201 405
Not Measurable disease 173 177 350
[1]
Measure Description:

Measurability of the disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria:

Patients with measurable disease have at least one visceral or soft tissue metastatic lesion (including new lesion).

Patient with non-measurable disease have documented rising PSA levels or appearance of new lesion.
Extent of disease   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 377 participants 378 participants 755 participants
Metastatic 356 364 720
Locoregional Recurrence 20 14 34
Missing 1 0 1
[1]
Measure Description:

Extent of the disease at screening stage:

  • Metastatic: bone or visceral metastases.
  • Locoregional recurrence includes local recurrent tumor at the primary site, along the draining lymphatic channels, or within the draining lymphatic nodal basin.
Tumor Location: number of sites involved  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 377 participants 378 participants 755 participants
1 134 146 280
2 117 112 229
3 78 73 151
4 or more 43 44 87
Missing 5 3 8
1.Primary Outcome
Title Overall Survival
Hide Description

Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.

In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
Time Frame From the date of randomization up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 377 378
Median (95% Confidence Interval)
Unit of Measure: Months
12.7
(11.6 to 13.7)
15.1
(14.1 to 16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.
Method Log Rank
Comments Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)
2.Secondary Outcome
Title Time to Progression Free Survival (PFS)
Hide Description Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
Time Frame From the date of randomization up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 377 378
Median (95% Confidence Interval)
Unit of Measure: Months
1.4
(1.4 to 1.7)
2.8
(2.4 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Overall Tumor Response
Hide Description

Tumor Overall Response Rate (ORR) (only in patients with measurable disease):

Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.

Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.

Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.
Time Frame From the date of randomization up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 204 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.4
(1.6 to 7.2)
14.4
(9.6 to 19.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Time to Tumor Progression
Hide Description Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
Time Frame From the date of randomization up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 377 378
Median (95% Confidence Interval)
Unit of Measure: Months
5.4
(4.7 to 6.5)
8.8
(7.4 to 9.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Log-rank comparisons stratified according to disease measurability and ECOG performance status.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.49 to 0.76
Estimation Comments Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.
5.Secondary Outcome
Title Time to Prostatic Specific Antigen (PSA) Progression
Hide Description

In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.

In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
Time Frame at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 377 378
Median (95% Confidence Interval)
Unit of Measure: Months
3.1
(2.2 to 4.4)
6.4
(5.1 to 7.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Log Rank
Comments Log-rank comparisons stratified according to disease measurability and ECOG performance status.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.63 to 0.90
Estimation Comments Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.
6.Secondary Outcome
Title PSA (Prostate-Specific Antigen) Response
Hide Description PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
Time Frame from baseline up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA >20ng/mL.
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 325 329
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.8
(13.7 to 22.0)
39.2
(33.9 to 44.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Time to Pain Progression
Hide Description

Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.

Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)
Time Frame from baseline up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of > 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 377 378
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
11.1 [2] 
(8.1 to NA)
[1]
Median not reached
[2]
Upper confidence interval unevaluable
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5192
Comments [Not Specified]
Method Log Rank
Comments Log-rank comparisons stratified according to disease measurability and ECOG performance status.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.69 to 1.19
Estimation Comments Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.
8.Secondary Outcome
Title Pain Response
Hide Description Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.
Time Frame from baseline up to 104 weeks (study cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description:
mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Overall Number of Participants Analyzed 168 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
7.7
(3.7 to 11.8)
9.2
(4.9 to 13.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitoxantrone + Prednisone, Cabazitaxel + Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6286
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).
Adverse Event Reporting Description The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.
 
Arm/Group Title Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Hide Arm/Group Description mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
All-Cause Mortality
Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   77/371 (20.75%)   145/371 (39.08%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  4/371 (1.08%)  25/371 (6.74%) 
Neutropenia * 1  3/371 (0.81%)  18/371 (4.85%) 
Leukopenia * 1  0/371 (0.00%)  3/371 (0.81%) 
Anaemia * 1  2/371 (0.54%)  2/371 (0.54%) 
Thrombocytopenia * 1  0/371 (0.00%)  2/371 (0.54%) 
Pancytopenia * 1  1/371 (0.27%)  0/371 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  1/371 (0.27%)  2/371 (0.54%) 
Cardiac arrest * 1  0/371 (0.00%)  2/371 (0.54%) 
Cardiac failure * 1  0/371 (0.00%)  2/371 (0.54%) 
Ventricular fibrillation * 1  0/371 (0.00%)  1/371 (0.27%) 
Cardiotoxicity * 1  1/371 (0.27%)  0/371 (0.00%) 
Myocardial infarction * 1  1/371 (0.27%)  0/371 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/371 (0.00%)  9/371 (2.43%) 
Vomiting * 1  2/371 (0.54%)  6/371 (1.62%) 
Abdominal pain * 1  0/371 (0.00%)  6/371 (1.62%) 
Constipation * 1  1/371 (0.27%)  3/371 (0.81%) 
Nausea * 1  1/371 (0.27%)  3/371 (0.81%) 
Intestinal obstruction * 1  0/371 (0.00%)  3/371 (0.81%) 
Rectal haemorrhage * 1  0/371 (0.00%)  2/371 (0.54%) 
Abdominal pain lower * 1  0/371 (0.00%)  1/371 (0.27%) 
Caecitis * 1  0/371 (0.00%)  1/371 (0.27%) 
Duodenal ulcer perforation * 1  0/371 (0.00%)  1/371 (0.27%) 
Dysphagia * 1  0/371 (0.00%)  1/371 (0.27%) 
Enterocolitis * 1  0/371 (0.00%)  1/371 (0.27%) 
Enterovesical fistula * 1  0/371 (0.00%)  1/371 (0.27%) 
Gastric ulcer * 1  0/371 (0.00%)  1/371 (0.27%) 
Haemorrhoidal haemorrhage * 1  0/371 (0.00%)  1/371 (0.27%) 
Mesenteric vein thrombosis * 1  0/371 (0.00%)  1/371 (0.27%) 
Oesophageal ulcer * 1  0/371 (0.00%)  1/371 (0.27%) 
Haematemesis * 1  2/371 (0.54%)  0/371 (0.00%) 
Pancreatic mass * 1  1/371 (0.27%)  0/371 (0.00%) 
Pancreatitis * 1  1/371 (0.27%)  0/371 (0.00%) 
Proctalgia * 1  1/371 (0.27%)  0/371 (0.00%) 
General disorders     
Pyrexia * 1  1/371 (0.27%)  6/371 (1.62%) 
Asthenia * 1  0/371 (0.00%)  2/371 (0.54%) 
Chest pain * 1  0/371 (0.00%)  2/371 (0.54%) 
Disease progression * 1  11/371 (2.96%)  1/371 (0.27%) 
Fatigue * 1  0/371 (0.00%)  1/371 (0.27%) 
Influenza like illness * 1  0/371 (0.00%)  1/371 (0.27%) 
Oedema peripheral * 1  0/371 (0.00%)  1/371 (0.27%) 
Pain * 1  0/371 (0.00%)  1/371 (0.27%) 
Sudden death * 1  0/371 (0.00%)  1/371 (0.27%) 
Hepatobiliary disorders     
Bile duct stone * 1  0/371 (0.00%)  1/371 (0.27%) 
Biliary colic * 1  0/371 (0.00%)  1/371 (0.27%) 
Cholecystitis * 1  0/371 (0.00%)  1/371 (0.27%) 
Cholangitis * 1  1/371 (0.27%)  0/371 (0.00%) 
Hepatic failure * 1  1/371 (0.27%)  0/371 (0.00%) 
Immune system disorders     
Anaphylactic shock * 1  0/371 (0.00%)  1/371 (0.27%) 
Infections and infestations     
Pneumonia * 1  2/371 (0.54%)  6/371 (1.62%) 
Urinary tract infection * 1  3/371 (0.81%)  4/371 (1.08%) 
Sepsis * 1  0/371 (0.00%)  4/371 (1.08%) 
Septic shock * 1  0/371 (0.00%)  4/371 (1.08%) 
Neutropenic sepsis * 1  1/371 (0.27%)  3/371 (0.81%) 
Infection * 1  2/371 (0.54%)  2/371 (0.54%) 
Neutropenic infection * 1  0/371 (0.00%)  2/371 (0.54%) 
Salmonellosis * 1  0/371 (0.00%)  2/371 (0.54%) 
Cellulitis * 1  2/371 (0.54%)  1/371 (0.27%) 
Urosepsis * 1  2/371 (0.54%)  1/371 (0.27%) 
Cystitis * 1  1/371 (0.27%)  1/371 (0.27%) 
Lobar pneumonia * 1  1/371 (0.27%)  1/371 (0.27%) 
Bacteraemia * 1  0/371 (0.00%)  1/371 (0.27%) 
Bronchopneumonia * 1  0/371 (0.00%)  1/371 (0.27%) 
Campylobacter infection * 1  0/371 (0.00%)  1/371 (0.27%) 
Fungal sepsis * 1  0/371 (0.00%)  1/371 (0.27%) 
Groin abscess * 1  0/371 (0.00%)  1/371 (0.27%) 
Implant site cellulitis * 1  0/371 (0.00%)  1/371 (0.27%) 
Oesophageal candidiasis * 1  0/371 (0.00%)  1/371 (0.27%) 
Pneumonia klebsiella * 1  0/371 (0.00%)  1/371 (0.27%) 
Urinary tract infection enterococcal * 1  0/371 (0.00%)  1/371 (0.27%) 
Urinary tract infection fungal * 1  0/371 (0.00%)  1/371 (0.27%) 
Bacterial sepsis * 1  1/371 (0.27%)  0/371 (0.00%) 
Febrile infection * 1  1/371 (0.27%)  0/371 (0.00%) 
Pneumococcal sepsis * 1  1/371 (0.27%)  0/371 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture * 1  1/371 (0.27%)  2/371 (0.54%) 
Ankle fracture * 1  0/371 (0.00%)  1/371 (0.27%) 
Femur fracture * 1  0/371 (0.00%)  1/371 (0.27%) 
Accidental overdose * 1  1/371 (0.27%)  0/371 (0.00%) 
Alcohol poisoning * 1  1/371 (0.27%)  0/371 (0.00%) 
Fracture * 1  1/371 (0.27%)  0/371 (0.00%) 
Multiple fractures * 1  1/371 (0.27%)  0/371 (0.00%) 
Tibia fracture * 1  1/371 (0.27%)  0/371 (0.00%) 
Investigations     
Eastern cooperative oncology group performance status worsened * 1  0/371 (0.00%)  1/371 (0.27%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/371 (0.27%)  4/371 (1.08%) 
Electrolyte imbalance * 1  0/371 (0.00%)  1/371 (0.27%) 
Hyperglycaemia * 1  0/371 (0.00%)  1/371 (0.27%) 
Hyperkalaemia * 1  0/371 (0.00%)  1/371 (0.27%) 
Hypoalbuminaemia * 1  0/371 (0.00%)  1/371 (0.27%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  4/371 (1.08%)  3/371 (0.81%) 
Pain in extremity * 1  2/371 (0.54%)  2/371 (0.54%) 
Osteonecrosis * 1  2/371 (0.54%)  1/371 (0.27%) 
Flank pain * 1  0/371 (0.00%)  1/371 (0.27%) 
Arthralgia * 1  1/371 (0.27%)  0/371 (0.00%) 
Spinal column stenosis * 1  1/371 (0.27%)  0/371 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain * 1  1/371 (0.27%)  1/371 (0.27%) 
Metastatic pain * 1  1/371 (0.27%)  1/371 (0.27%) 
Gastric cancer * 1  1/371 (0.27%)  0/371 (0.00%) 
Metastases to meninges * 1  1/371 (0.27%)  0/371 (0.00%) 
Metastases to spine * 1  1/371 (0.27%)  0/371 (0.00%) 
Prostate cancer metastatic * 1  1/371 (0.27%)  0/371 (0.00%) 
Nervous system disorders     
Spinal cord compression * 1  3/371 (0.81%)  4/371 (1.08%) 
Syncope * 1  1/371 (0.27%)  2/371 (0.54%) 
Cerebral haemorrhage * 1  0/371 (0.00%)  1/371 (0.27%) 
Grand mal convulsion * 1  0/371 (0.00%)  1/371 (0.27%) 
Metabolic encephalopathy * 1  0/371 (0.00%)  1/371 (0.27%) 
Neuropathy peripheral * 1  0/371 (0.00%)  1/371 (0.27%) 
Presyncope * 1  0/371 (0.00%)  1/371 (0.27%) 
Speech disorder * 1  0/371 (0.00%)  1/371 (0.27%) 
Vith nerve paralysis * 1  0/371 (0.00%)  1/371 (0.27%) 
Altered state of consciousness * 1  1/371 (0.27%)  0/371 (0.00%) 
Cerebral infarction * 1  1/371 (0.27%)  0/371 (0.00%) 
Cerebrovascular accident * 1  1/371 (0.27%)  0/371 (0.00%) 
Cranial nerve paralysis * 1  1/371 (0.27%)  0/371 (0.00%) 
Epiduritis * 1  1/371 (0.27%)  0/371 (0.00%) 
Peripheral motor neuropathy * 1  1/371 (0.27%)  0/371 (0.00%) 
Vestibular nystagmus * 1  1/371 (0.27%)  0/371 (0.00%) 
Psychiatric disorders     
Confusional state * 1  3/371 (0.81%)  1/371 (0.27%) 
Suicidal ideation * 1  0/371 (0.00%)  1/371 (0.27%) 
Psychotic disorder * 1  1/371 (0.27%)  0/371 (0.00%) 
Renal and urinary disorders     
Haematuria * 1  3/371 (0.81%)  10/371 (2.70%) 
Renal failure * 1  0/371 (0.00%)  6/371 (1.62%) 
Renal failure acute * 1  0/371 (0.00%)  5/371 (1.35%) 
Hydronephrosis * 1  1/371 (0.27%)  4/371 (1.08%) 
Ureteric obstruction * 1  0/371 (0.00%)  4/371 (1.08%) 
Urinary retention * 1  2/371 (0.54%)  2/371 (0.54%) 
Ureteric stenosis * 1  1/371 (0.27%)  1/371 (0.27%) 
Bladder neck obstruction * 1  0/371 (0.00%)  1/371 (0.27%) 
Renal colic * 1  0/371 (0.00%)  1/371 (0.27%) 
Urethral pain * 1  0/371 (0.00%)  1/371 (0.27%) 
Urethral stenosis * 1  0/371 (0.00%)  1/371 (0.27%) 
Urinary tract obstruction * 1  0/371 (0.00%)  1/371 (0.27%) 
Postrenal failure * 1  1/371 (0.27%)  0/371 (0.00%) 
Reproductive system and breast disorders     
Penile oedema * 1  1/371 (0.27%)  0/371 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  6/371 (1.62%)  5/371 (1.35%) 
Dyspnoea * 1  1/371 (0.27%)  3/371 (0.81%) 
Respiratory failure * 1  0/371 (0.00%)  2/371 (0.54%) 
Aspiration * 1  0/371 (0.00%)  1/371 (0.27%) 
Chylothorax * 1  0/371 (0.00%)  1/371 (0.27%) 
Hypoxia * 1  0/371 (0.00%)  1/371 (0.27%) 
Pneumonitis * 1  0/371 (0.00%)  1/371 (0.27%) 
Chronic obstructive pulmonary disease * 1  1/371 (0.27%)  0/371 (0.00%) 
Pleural effusion * 1  1/371 (0.27%)  0/371 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  2/371 (0.54%)  2/371 (0.54%) 
Haematoma * 1  0/371 (0.00%)  1/371 (0.27%) 
Hypotension * 1  0/371 (0.00%)  1/371 (0.27%) 
Orthostatic hypotension * 1  0/371 (0.00%)  1/371 (0.27%) 
Extremity necrosis * 1  1/371 (0.27%)  0/371 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mitoxantrone + Prednisone Cabazitaxel + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   323/371 (87.06%)   350/371 (94.34%) 
Blood and lymphatic system disorders     
Neutropenia * 1  38/371 (10.24%)  66/371 (17.79%) 
Anaemia * 1  18/371 (4.85%)  38/371 (10.24%) 
Gastrointestinal disorders     
Diarrhoea * 1  39/371 (10.51%)  170/371 (45.82%) 
Nausea * 1  84/371 (22.64%)  127/371 (34.23%) 
Vomiting * 1  36/371 (9.70%)  80/371 (21.56%) 
Constipation * 1  56/371 (15.09%)  73/371 (19.68%) 
Abdominal pain * 1  13/371 (3.50%)  38/371 (10.24%) 
Dyspepsia * 1  6/371 (1.62%)  25/371 (6.74%) 
Abdominal pain upper * 1  5/371 (1.35%)  20/371 (5.39%) 
General disorders     
Fatigue * 1  102/371 (27.49%)  136/371 (36.66%) 
Asthenia * 1  46/371 (12.40%)  76/371 (20.49%) 
Pyrexia * 1  22/371 (5.93%)  40/371 (10.78%) 
Oedema peripheral * 1  34/371 (9.16%)  34/371 (9.16%) 
Mucosal inflammation * 1  10/371 (2.70%)  22/371 (5.93%) 
Pain * 1  18/371 (4.85%)  19/371 (5.12%) 
Infections and infestations     
Urinary tract infection * 1  9/371 (2.43%)  24/371 (6.47%) 
Investigations     
Weight decreased * 1  28/371 (7.55%)  32/371 (8.63%) 
Metabolism and nutrition disorders     
Anorexia * 1  39/371 (10.51%)  59/371 (15.90%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  41/371 (11.05%)  58/371 (15.63%) 
Arthralgia * 1  31/371 (8.36%)  39/371 (10.51%) 
Pain in extremity * 1  27/371 (7.28%)  29/371 (7.82%) 
Muscle spasms * 1  10/371 (2.70%)  27/371 (7.28%) 
Bone pain * 1  19/371 (5.12%)  19/371 (5.12%) 
Musculoskeletal pain * 1  20/371 (5.39%)  18/371 (4.85%) 
Nervous system disorders     
Dysgeusia * 1  15/371 (4.04%)  41/371 (11.05%) 
Dizziness * 1  21/371 (5.66%)  30/371 (8.09%) 
Neuropathy peripheral * 1  4/371 (1.08%)  30/371 (8.09%) 
Headache * 1  19/371 (5.12%)  28/371 (7.55%) 
Peripheral sensory neuropathy * 1  5/371 (1.35%)  20/371 (5.39%) 
Renal and urinary disorders     
Haematuria * 1  13/371 (3.50%)  58/371 (15.63%) 
Dysuria * 1  5/371 (1.35%)  25/371 (6.74%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  16/371 (4.31%)  43/371 (11.59%) 
Cough * 1  22/371 (5.93%)  40/371 (10.78%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  18/371 (4.85%)  37/371 (9.97%) 
Vascular disorders     
Hypotension * 1  9/371 (2.43%)  19/371 (5.12%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
[Not Specified]
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.
Publication of the study will be made jointly in the name of all wholehearted collaborators. Other papers will be authored based on the contributions of the individuals to the overall study. Substudies with scientific merit which have received prior approval from the Steering Committee (SC) may be published in the names of the contributing investigators. A copy of all manuscripts will be provided to the sponsors for their review. The final decision to publish articles will be made by the SC.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: International Clinical Development Study Director
Organization: sanofi-aventis
EMail: GV-Contact-us@sanofi-aventis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00417079    
Other Study ID Numbers: EFC6193
First Submitted: December 28, 2006
First Posted: December 29, 2006
Results First Submitted: September 20, 2010
Results First Posted: December 23, 2010
Last Update Posted: March 10, 2011