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To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

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: NCT00715078
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Biological: sipuleucel-T
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A Cohort B Cohort C
Hide Arm/Group Description Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Period Title: Overall Study
Started 41 40 41
Received ≥ 1 Study Infusion 40 40 39
Received ≥ 1 Leukapheresis 40 40 40
Completed 11 4 3
Not Completed 30 36 38
Reason Not Completed
Death             29             36             36
Withdrawal by Subject             1             0             1
Unable to start due to disease prog.             0             0             1
Arm/Group Title Cohort A Cohort B Cohort C Total
Hide Arm/Group Description Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Total of all reporting groups
Overall Number of Baseline Participants 41 40 41 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  26.8%
9
  22.5%
11
  26.8%
31
  25.4%
>=65 years
30
  73.2%
31
  77.5%
30
  73.2%
91
  74.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 41 participants 122 participants
71.0  (8.25) 71.8  (8.29) 68.6  (7.5) 70.5  (8.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 122 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
40
 100.0%
41
 100.0%
122
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 122 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
5
  12.5%
0
   0.0%
5
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.3%
0
   0.0%
3
   7.3%
6
   4.9%
White
38
  92.7%
35
  87.5%
38
  92.7%
111
  91.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 41 participants 40 participants 41 participants 122 participants
41
 100.0%
40
 100.0%
41
 100.0%
122
 100.0%
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 41 participants 40 participants 41 participants 122 participants
ECOG 0=Fully Active; No restrictions
29
  70.7%
24
  60.0%
27
  65.9%
80
  65.6%
ECOG 1= Restricted Strenuous Activity
12
  29.3%
16
  40.0%
14
  34.1%
42
  34.4%
[1]
Measure Description: ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 41 participants 40 participants 41 participants 122 participants
Gleason Score ≤ 6
7
  17.1%
8
  20.0%
4
   9.8%
19
  15.6%
Gleason Score =7
12
  29.3%
15
  37.5%
14
  34.1%
41
  33.6%
Gleason Score ≥ 8
22
  53.7%
16
  40.0%
23
  56.1%
61
  50.0%
Missing information
0
   0.0%
1
   2.5%
0
   0.0%
1
   0.8%
[1]
Measure Description: Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.
1.Primary Outcome
Title Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.
Hide Description An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
Time Frame Baseline, Months 2, 4 and 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.
Arm/Group Title Cohort A Cohort B Cohort C
Hide Arm/Group Description:
Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Overall Number of Participants Analyzed 40 36 37
Mean (Standard Error)
Unit of Measure: Ratio ofCD54 molecules on BDS65:FP cells
29.53  (1.285) 30.94  (1.418) 26.67  (1.194)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A, Cohort B
Comments The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.
Statistical Test of Hypothesis P-Value 0.5019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means (GeoMean)
Estimated Value 1.046
Confidence Interval (2-Sided) 90%
0.936 to 1.168
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A, Cohort C
Comments The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.
Statistical Test of Hypothesis P-Value 0.1443
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter the ratio of geometric means
Estimated Value 0.907
Confidence Interval (2-Sided) 90%
0.813 to 1.013
Estimation Comments [Not Specified]
Time Frame Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first.
Adverse Event Reporting Description Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
 
Arm/Group Title Cohort A Cohort B Cohort C
Hide Arm/Group Description Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
All-Cause Mortality
Cohort A Cohort B Cohort C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/40 (72.50%)      36/40 (90.00%)      36/40 (90.00%)    
Hide Serious Adverse Events
Cohort A Cohort B Cohort C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/40 (25.00%)      9/40 (22.50%)      11/40 (27.50%)    
Blood and lymphatic system disorders       
ANAEMIA † 1  0/40 (0.00%)  0 3/40 (7.50%)  3 0/40 (0.00%)  0
DISSEMINATED INTRAVASCULAR COAGULATION † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
ANGINA PECTORIS † 1  0/40 (0.00%)  0 1/40 (2.50%)  2 0/40 (0.00%)  0
ATRIAL FIBRILLATION † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 1/40 (2.50%)  1
ATRIOVENTRICULAR BLOCK COMPLETE † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
ATRIOVENTRICULAR BLOCK SECOND DEGREE † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
BRADYCARDIA † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
CARDIAC FAILURE CONGESTIVE † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
CARDIO-RESPIRATORY ARREST † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
CORONARY ARTERY DISEASE † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Ear and labyrinth disorders       
VERTIGO † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders       
ILEUS † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
General disorders       
ASTHENIA † 1  3/40 (7.50%)  3 1/40 (2.50%)  1 0/40 (0.00%)  0
CHILLS † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
DISEASE PROGRESSION † 1  1/40 (2.50%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
FATIGUE † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
NON-CARDIAC CHEST PAIN † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
PYREXIA † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations       
BACTERAEMIA † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
DEVICE RELATED INFECTION † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
PNEUMONIA † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
SEPSIS † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
URINARY TRACT INFECTION † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
UROSEPSIS † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Injury, poisoning and procedural complications       
CERVICAL VERTEBRAL FRACTURE † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
HIP FRACTURE † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
WOUND † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders       
DEHYDRATION † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
HYPERGLYCAEMIA † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
HYPOCALCAEMIA † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
HYPONATRAEMIA † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders       
CEREBRAL INFARCTION † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 1/40 (2.50%)  1
CEREBROVASCULAR ACCIDENT † 1  1/40 (2.50%)  1 1/40 (2.50%)  1 2/40 (5.00%)  2
INTRACRANIAL TUMOUR HAEMORRHAGE † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
SPINAL CORD COMPRESSION † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
SYNCOPE † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 1/40 (2.50%)  1
TRANSIENT ISCHAEMIC ATTACK † 1  0/40 (0.00%)  0 1/40 (2.50%)  2 1/40 (2.50%)  1
Psychiatric disorders       
CONFUSIONAL STATE † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
Renal and urinary disorders       
BLADDER OUTLET OBSTRUCTION † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
HYDRONEPHROSIS † 1  1/40 (2.50%)  1 2/40 (5.00%)  2 0/40 (0.00%)  0
RENAL FAILURE ACUTE † 1  1/40 (2.50%)  1 1/40 (2.50%)  1 0/40 (0.00%)  0
URETHRAL STENOSIS † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  2
DYSPNOEA † 1  1/40 (2.50%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
HYPOXIA † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
Vascular disorders       
DEEP VEIN THROMBOSIS † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA 14.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B Cohort C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/40 (95.00%)      40/40 (100.00%)      40/40 (100.00%)    
Blood and lymphatic system disorders       
ANAEMIA † 1  6/40 (15.00%)  6 4/40 (10.00%)  5 8/40 (20.00%)  8
Gastrointestinal disorders       
ABDOMINAL DISCOMFORT † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
ABDOMINAL PAIN † 1  4/40 (10.00%)  4 2/40 (5.00%)  3 3/40 (7.50%)  3
ABDOMINAL PAIN UPPER † 1  2/40 (5.00%)  2 2/40 (5.00%)  2 2/40 (5.00%)  3
CONSTIPATION † 1  9/40 (22.50%)  10 8/40 (20.00%)  9 6/40 (15.00%)  7
DIARRHOEA † 1  4/40 (10.00%)  5 4/40 (10.00%)  4 3/40 (7.50%)  3
DYSPEPSIA † 1  4/40 (10.00%)  4 2/40 (5.00%)  2 0/40 (0.00%)  0
DYSPHAGIA † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
FLATULENCE † 1  1/40 (2.50%)  1 2/40 (5.00%)  2 0/40 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE † 1  2/40 (5.00%)  2 1/40 (2.50%)  1 0/40 (0.00%)  0
NAUSEA † 1  16/40 (40.00%)  20 11/40 (27.50%)  11 11/40 (27.50%)  12
RETCHING † 1  2/40 (5.00%)  2 1/40 (2.50%)  1 0/40 (0.00%)  0
VOMITING † 1  8/40 (20.00%)  9 5/40 (12.50%)  5 5/40 (12.50%)  6
PARAESTHESIA ORAL * 2  2/40 (5.00%)  4 3/40 (7.50%)  5 5/40 (12.50%)  9
HYPOAESTHESIA ORAL * 1  3/40 (7.50%)  3 1/40 (2.50%)  1 2/40 (5.00%)  2
General disorders       
ASTHENIA † 1  2/40 (5.00%)  2 3/40 (7.50%)  3 4/40 (10.00%)  5
CHEST DISCOMFORT † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
CHEST PAIN † 1  6/40 (15.00%)  6 0/40 (0.00%)  0 2/40 (5.00%)  2
CHILLS † 1  9/40 (22.50%)  15 13/40 (32.50%)  25 10/40 (25.00%)  15
FATIGUE † 1  20/40 (50.00%)  23 20/40 (50.00%)  27 16/40 (40.00%)  17
INFLUENZA LIKE ILLNESS † 1  4/40 (10.00%)  6 0/40 (0.00%)  0 4/40 (10.00%)  6
MALAISE † 1  1/40 (2.50%)  2 0/40 (0.00%)  0 2/40 (5.00%)  2
OEDEMA PERIPHERAL † 1  6/40 (15.00%)  6 9/40 (22.50%)  10 4/40 (10.00%)  5
PAIN † 1  0/40 (0.00%)  0 4/40 (10.00%)  6 1/40 (2.50%)  1
PYREXIA † 1  5/40 (12.50%)  6 4/40 (10.00%)  5 7/40 (17.50%)  8
Infections and infestations       
BRONCHITIS † 1  0/40 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
GASTROENTERITIS VIRAL † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
NASOPHARYNGITIS † 1  3/40 (7.50%)  3 3/40 (7.50%)  3 1/40 (2.50%)  1
PNEUMONIA † 1  0/40 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
UPPER RESPIRATORY TRACT INFECTION † 1  2/40 (5.00%)  3 2/40 (5.00%)  2 2/40 (5.00%)  2
URINARY TRACT INFECTION † 1  2/40 (5.00%)  2 5/40 (12.50%)  6 1/40 (2.50%)  1
VIRAL INFECTION † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
Injury, poisoning and procedural complications       
CITRATE TOXICITY † 1  5/40 (12.50%)  10 4/40 (10.00%)  7 6/40 (15.00%)  13
CONTUSION † 1  3/40 (7.50%)  3 2/40 (5.00%)  2 1/40 (2.50%)  1
FALL † 1  2/40 (5.00%)  2 1/40 (2.50%)  1 2/40 (5.00%)  4
LACERATION † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 2/40 (5.00%)  3
Investigations       
BLOOD PRESSURE INCREASED † 1  2/40 (5.00%)  2 1/40 (2.50%)  1 2/40 (5.00%)  7
WEIGHT DECREASED † 1  7/40 (17.50%)  7 5/40 (12.50%)  5 3/40 (7.50%)  3
Metabolism and nutrition disorders       
DECREASED APPETITE † 1  7/40 (17.50%)  8 10/40 (25.00%)  10 8/40 (20.00%)  8
DEHYDRATION † 1  8/40 (20.00%)  12 4/40 (10.00%)  8 4/40 (10.00%)  6
HYPOKALAEMIA † 1  0/40 (0.00%)  0 0/40 (0.00%)  0 2/40 (5.00%)  2
HYPONATRAEMIA † 1  0/40 (0.00%)  0 2/40 (5.00%)  2 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA † 1  11/40 (27.50%)  16 13/40 (32.50%)  19 7/40 (17.50%)  13
BACK PAIN † 1  10/40 (25.00%)  15 16/40 (40.00%)  21 12/40 (30.00%)  16
BONE PAIN † 1  3/40 (7.50%)  3 0/40 (0.00%)  0 5/40 (12.50%)  5
FLANK PAIN † 1  4/40 (10.00%)  5 4/40 (10.00%)  4 1/40 (2.50%)  1
GROIN PAIN † 1  1/40 (2.50%)  1 1/40 (2.50%)  1 2/40 (5.00%)  2
MUSCLE SPASMS † 1  4/40 (10.00%)  4 6/40 (15.00%)  7 2/40 (5.00%)  2
MUSCULAR WEAKNESS † 1  0/40 (0.00%)  0 3/40 (7.50%)  3 2/40 (5.00%)  2
MUSCULOSKELETAL CHEST PAIN † 1  4/40 (10.00%)  4 1/40 (2.50%)  1 1/40 (2.50%)  1
MUSCULOSKELETAL DISCOMFORT † 1  1/40 (2.50%)  1 2/40 (5.00%)  3 0/40 (0.00%)  0
MUSCULOSKELETAL PAIN † 1  8/40 (20.00%)  9 4/40 (10.00%)  5 12/40 (30.00%)  13
MYALGIA † 1  7/40 (17.50%)  8 5/40 (12.50%)  5 4/40 (10.00%)  5
NECK PAIN † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 1/40 (2.50%)  1
PAIN IN EXTREMITY † 1  6/40 (15.00%)  8 3/40 (7.50%)  6 9/40 (22.50%)  9
Nervous system disorders       
DIZZINESS † 1  6/40 (15.00%)  7 6/40 (15.00%)  6 8/40 (20.00%)  11
DYSGEUSIA † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 2/40 (5.00%)  2
HEADACHE † 1  4/40 (10.00%)  5 3/40 (7.50%)  3 7/40 (17.50%)  8
HYPOAESTHESIA † 1  1/40 (2.50%)  1 5/40 (12.50%)  11 1/40 (2.50%)  1
PARAESTHESIA † 1  3/40 (7.50%)  3 9/40 (22.50%)  12 5/40 (12.50%)  5
RESTLESS LEGS SYNDROME † 1  1/40 (2.50%)  1 2/40 (5.00%)  3 2/40 (5.00%)  3
SOMNOLENCE † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 1/40 (2.50%)  1
TREMOR † 1  2/40 (5.00%)  2 1/40 (2.50%)  1 2/40 (5.00%)  2
Psychiatric disorders       
AGITATION † 1  0/40 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
ANXIETY † 1  3/40 (7.50%)  4 6/40 (15.00%)  7 3/40 (7.50%)  3
DEPRESSION † 1  5/40 (12.50%)  5 1/40 (2.50%)  1 3/40 (7.50%)  3
INSOMNIA † 1  3/40 (7.50%)  3 5/40 (12.50%)  5 6/40 (15.00%)  6
Renal and urinary disorders       
HAEMATURIA † 1  5/40 (12.50%)  6 4/40 (10.00%)  6 1/40 (2.50%)  1
HYDRONEPHROSIS † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 2/40 (5.00%)  2
NEPHROLITHIASIS † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
NOCTURIA † 1  2/40 (5.00%)  2 5/40 (12.50%)  5 2/40 (5.00%)  2
POLLAKIURIA † 1  1/40 (2.50%)  1 4/40 (10.00%)  4 0/40 (0.00%)  0
URINARY RETENTION † 1  0/40 (0.00%)  0 3/40 (7.50%)  3 3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders       
COUGH † 1  4/40 (10.00%)  4 2/40 (5.00%)  2 3/40 (7.50%)  3
DYSPNOEA † 1  3/40 (7.50%)  3 4/40 (10.00%)  4 3/40 (7.50%)  3
DYSPNOEA EXERTIONAL † 1  1/40 (2.50%)  1 2/40 (5.00%)  2 3/40 (7.50%)  3
PRODUCTIVE COUGH † 1  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders       
ECCHYMOSIS † 1  3/40 (7.50%)  4 1/40 (2.50%)  1 0/40 (0.00%)  0
HYPERHIDROSIS † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 2/40 (5.00%)  2
RASH † 1  1/40 (2.50%)  1 2/40 (5.00%)  2 2/40 (5.00%)  2
Vascular disorders       
HAEMATOMA † 1  3/40 (7.50%)  3 2/40 (5.00%)  2 0/40 (0.00%)  0
HOT FLUSH † 1  1/40 (2.50%)  1 1/40 (2.50%)  1 2/40 (5.00%)  3
HYPERTENSION † 1  3/40 (7.50%)  6 4/40 (10.00%)  5 2/40 (5.00%)  2
HYPOTENSION † 1  1/40 (2.50%)  1 0/40 (0.00%)  0 4/40 (10.00%)  4
1
Term from vocabulary, MedDRA 14.1
2
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[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.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shabnam Vaziri
Organization: Dendreon
Phone: 206-455-2323
EMail: Svaziri@Dendreon.com
Layout table for additonal information
Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00715078    
Other Study ID Numbers: P07-2
First Submitted: July 11, 2008
First Posted: July 15, 2008
Results First Submitted: February 19, 2014
Results First Posted: May 12, 2014
Last Update Posted: May 23, 2017