Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    tcd12128
Previous Study | Return to List | Next Study

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer

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: NCT01511536
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : November 4, 2015
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Cabazitaxel XRP6258
Drug: Abiraterone acetate
Drug: Prednisone 5 mg
Enrollment 38
Recruitment Details Participants were enrolled at 2 centers in phase 1 part and 3 centers in phase 2 part between March 2012 and April 2014.
Pre-assignment Details Phase I was a dose escalation part of Cabazitaxel, administered with a constant dose of abiraterone, to determine maximally tolerated dose. Phase 2 was efficacy and safety evaluation of Cabazitaxel at a dose, determined in Phase 1, in combination with abiraterone.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Period Title: Phase 1
Started 3 7 0 [1]
Completed 3 [2] 6 [2] 0
Not Completed 0 1 0
Reason Not Completed
Other             0             1             0
[1]
Phase 1 and phase 2 are separate populations.
[2]
Cancer progression,adverse event,consent withdrawal are considered as completed(defined in protocol)
Period Title: Phase 2
Started 0 0 27
Completed 0 0 18 [1]
Not Completed 0 0 9
Reason Not Completed
Other             0             0             9
[1]
Cancer progression,adverse event,consent withdrawal are considered as completed(defined in protocol)
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Total
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 3 7 27 37
Hide Baseline Analysis Population Description
All treated/safety population defined as all registered participants exposed to both investigational medicinal product (IMP) components, regardless of the amount of treatment administered.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 7 participants 27 participants 37 participants
71.0  (7.0) 60.0  (10.0) 67.1  (5.4) 66.1  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 27 participants 37 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
7
 100.0%
27
 100.0%
37
 100.0%
1.Primary Outcome
Title Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate
Hide Description MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.
Time Frame Up to Cycle 2 of Phase 1 (up to 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.
Arm/Group Title Phase 1: Overall Population
Hide Arm/Group Description:
Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg/m^2
25
2.Primary Outcome
Title Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response
Hide Description Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.
Time Frame Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.2
(26.6 to 66.6)
3.Secondary Outcome
Title Phase 2: Objective Progression Free Survival (PFS)
Hide Description

Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:

1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as 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 lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.

Analysis was performed by Kaplan-Meier method.

Time Frame From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy/activity population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(4.731 to NA)
[1]
Data was not calculable as <50% participants had event of interest.
4.Secondary Outcome
Title Phase 2: PSA Progression Free Survival
Hide Description

Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.

Analysis was performed by Kaplan Meire method.

Time Frame Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy/activity population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
6.93
(4.140 to 10.251)
5.Secondary Outcome
Title Phase 2: Percentage of Participants With Objective Response
Hide Description Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).
Time Frame Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.4
(4.7 to 50.8)
6.Secondary Outcome
Title Phase 2: Overall Survival
Hide Description Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.
Time Frame From baseline up to death or study cut-off (maximum duration: 603 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy/activity population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(9.429 to NA)
[1]
Data was not calculable as <50% participants had event of interest.
7.Secondary Outcome
Title Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)
Hide Description [Not Specified]
Time Frame 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
330  (187)
8.Secondary Outcome
Title Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)
Hide Description Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose
Time Frame 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
817  (117)
9.Secondary Outcome
Title Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)
Hide Description [Not Specified]
Time Frame 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: hour
91.6  (62.6)
10.Secondary Outcome
Title Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)
Hide Description [Not Specified]
Time Frame 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: L/h/m^2
31.4  (4.67)
11.Secondary Outcome
Title Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)
Hide Description [Not Specified]
Time Frame 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: L/m^2
2711  (2493)
12.Secondary Outcome
Title Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)
Hide Description [Not Specified]
Time Frame 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
216  (152)
13.Secondary Outcome
Title Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)
Hide Description [Not Specified]
Time Frame 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: hour
2.00
(1.00 to 6.00)
14.Secondary Outcome
Title Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)
Hide Description Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.
Time Frame 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
928  (466)
15.Secondary Outcome
Title Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)
Hide Description [Not Specified]
Time Frame Pre abiraterone dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Arm/Group Title Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg
Hide Arm/Group Description:
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
9.99  (13.0)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug [cabazitaxel or abiraterone, whichever came first] to last dose of study drug [cabazitaxel or abiraterone, whichever came last] + 30 days). Analysis was performed on safety population.
 
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
All-Cause Mortality
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   4/7 (57.14%)   21/27 (77.78%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Neutropenia  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Thrombocytopenia  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Cardiac disorders       
Cardiac failure  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Myocardial ischaemia  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Acute coronary syndrome  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Atrioventricular block  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Gastrointestinal disorders       
Abdominal pain  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Diarrhoea  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Vomiting  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
General disorders       
Fatigue  1  1/3 (33.33%)  1/7 (14.29%)  0/27 (0.00%) 
Asthenia  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Disease progression  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Non-cardiac chest pain  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Infections and infestations       
Device related infection  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Neutropenic infection  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Neutropenic sepsis  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Parasitic gastroenteritis  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Pneumonia  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Pneumonia bacterial  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Septic shock  1  0/3 (0.00%)  0/7 (0.00%)  3/27 (11.11%) 
Spinal cord infection  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Urinary tract infection  1  0/3 (0.00%)  0/7 (0.00%)  4/27 (14.81%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Bone pain  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Coccydynia  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Pain in extremity  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Small cell lung cancer  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Metastatic pain  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Nervous system disorders       
Peripheral motor neuropathy  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Spinal cord compression  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Psychiatric disorders       
Suicidal ideation  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Renal and urinary disorders       
Anuria  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Bladder obstruction  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Haematuria  1  0/3 (0.00%)  0/7 (0.00%)  3/27 (11.11%) 
Hydronephrosis  1  0/3 (0.00%)  0/7 (0.00%)  4/27 (14.81%) 
Renal colic  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Renal failure  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Renal failure acute  1  0/3 (0.00%)  0/7 (0.00%)  3/27 (11.11%) 
Urinary retention  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Reproductive system and breast disorders       
Prostatitis  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Pelvic pain  1  0/3 (0.00%)  0/7 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   7/7 (100.00%)   27/27 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  1/3 (33.33%)  0/7 (0.00%)  4/27 (14.81%) 
Neutropenia  1  0/3 (0.00%)  0/7 (0.00%)  4/27 (14.81%) 
Cardiac disorders       
Atrial fibrillation  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/3 (33.33%)  1/7 (14.29%)  2/27 (7.41%) 
Gastrointestinal disorders       
Abdominal pain  1  1/3 (33.33%)  2/7 (28.57%)  3/27 (11.11%) 
Abdominal pain upper  1  2/3 (66.67%)  1/7 (14.29%)  0/27 (0.00%) 
Anal fissure  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Constipation  1  2/3 (66.67%)  2/7 (28.57%)  6/27 (22.22%) 
Diarrhoea  1  2/3 (66.67%)  3/7 (42.86%)  15/27 (55.56%) 
Dry mouth  1  0/3 (0.00%)  0/7 (0.00%)  5/27 (18.52%) 
Dyspepsia  1  0/3 (0.00%)  2/7 (28.57%)  1/27 (3.70%) 
Gastrointestinal hypermotility  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Gastrointestinal motility disorder  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Gastrooesophageal reflux disease  1  0/3 (0.00%)  0/7 (0.00%)  4/27 (14.81%) 
Haemorrhoids  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Lip pain  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Nausea  1  1/3 (33.33%)  5/7 (71.43%)  14/27 (51.85%) 
Rectal haemorrhage  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Stomatitis  1  1/3 (33.33%)  2/7 (28.57%)  5/27 (18.52%) 
Toothache  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Vomiting  1  0/3 (0.00%)  0/7 (0.00%)  6/27 (22.22%) 
General disorders       
Asthenia  1  2/3 (66.67%)  3/7 (42.86%)  16/27 (59.26%) 
Fatigue  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Granuloma  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Non-cardiac chest pain  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Oedema peripheral  1  1/3 (33.33%)  1/7 (14.29%)  4/27 (14.81%) 
Pain  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Pyrexia  1  2/3 (66.67%)  0/7 (0.00%)  3/27 (11.11%) 
Infections and infestations       
Gastroenteritis  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Nasopharyngitis  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Oral candidiasis  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Oral fungal infection  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Tinea pedis  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Urinary tract infection  1  1/3 (33.33%)  0/7 (0.00%)  3/27 (11.11%) 
Investigations       
Alanine aminotransferase increased  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Aspartate aminotransferase increased  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Blood bilirubin increased  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Blood potassium increased  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Transaminases increased  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Weight decreased  1  0/3 (0.00%)  2/7 (28.57%)  13/27 (48.15%) 
Weight increased  1  1/3 (33.33%)  1/7 (14.29%)  2/27 (7.41%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/3 (33.33%)  1/7 (14.29%)  13/27 (48.15%) 
Dehydration  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Hypocalcaemia  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Hypokalaemia  1  0/3 (0.00%)  1/7 (14.29%)  7/27 (25.93%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Back pain  1  1/3 (33.33%)  2/7 (28.57%)  9/27 (33.33%) 
Bone pain  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Flank pain  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Muscle spasms  1  1/3 (33.33%)  0/7 (0.00%)  2/27 (7.41%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Musculoskeletal pain  1  1/3 (33.33%)  1/7 (14.29%)  4/27 (14.81%) 
Myalgia  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Neck pain  1  1/3 (33.33%)  0/7 (0.00%)  2/27 (7.41%) 
Pain in extremity  1  1/3 (33.33%)  1/7 (14.29%)  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Seborrhoeic keratosis  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Nervous system disorders       
Dysgeusia  1  0/3 (0.00%)  2/7 (28.57%)  4/27 (14.81%) 
Headache  1  1/3 (33.33%)  0/7 (0.00%)  3/27 (11.11%) 
Hyperaesthesia  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Paraesthesia  1  1/3 (33.33%)  2/7 (28.57%)  1/27 (3.70%) 
Peripheral motor neuropathy  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Peripheral sensory neuropathy  1  1/3 (33.33%)  0/7 (0.00%)  2/27 (7.41%) 
Syncope  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Psychiatric disorders       
Affective disorder  1  0/3 (0.00%)  0/7 (0.00%)  3/27 (11.11%) 
Insomnia  1  2/3 (66.67%)  0/7 (0.00%)  0/27 (0.00%) 
Renal and urinary disorders       
Dysuria  1  0/3 (0.00%)  1/7 (14.29%)  1/27 (3.70%) 
Haematuria  1  1/3 (33.33%)  2/7 (28.57%)  8/27 (29.63%) 
Pollakiuria  1  0/3 (0.00%)  0/7 (0.00%)  2/27 (7.41%) 
Reproductive system and breast disorders       
Pelvic pain  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/3 (33.33%)  1/7 (14.29%)  4/27 (14.81%) 
Dysphonia  1  0/3 (0.00%)  0/7 (0.00%)  4/27 (14.81%) 
Dyspnoea  1  0/3 (0.00%)  2/7 (28.57%)  11/27 (40.74%) 
Dyspnoea exertional  1  1/3 (33.33%)  0/7 (0.00%)  1/27 (3.70%) 
Pleural effusion  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Rhinorrhoea  1  1/3 (33.33%)  0/7 (0.00%)  2/27 (7.41%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  1/3 (33.33%)  2/7 (28.57%)  5/27 (18.52%) 
Hair disorder  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Hyperhidrosis  1  1/3 (33.33%)  1/7 (14.29%)  0/27 (0.00%) 
Intertrigo  1  0/3 (0.00%)  1/7 (14.29%)  0/27 (0.00%) 
Nail ridging  1  1/3 (33.33%)  0/7 (0.00%)  0/27 (0.00%) 
Onycholysis  1  1/3 (33.33%)  1/7 (14.29%)  0/27 (0.00%) 
Pruritus  1  0/3 (0.00%)  1/7 (14.29%)  2/27 (7.41%) 
Vascular disorders       
Flushing  1  0/3 (0.00%)  2/7 (28.57%)  2/27 (7.41%) 
Hot flush  1  1/3 (33.33%)  2/7 (28.57%)  1/27 (3.70%) 
Hypotension  1  1/3 (33.33%)  1/7 (14.29%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01511536     History of Changes
Other Study ID Numbers: TCD12128
2011-001506-96 ( EudraCT Number )
U1111-1121-6324 ( Other Identifier: UTN )
First Submitted: January 4, 2012
First Posted: January 18, 2012
Results First Submitted: October 2, 2015
Results First Posted: November 4, 2015
Last Update Posted: July 28, 2016