To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
Study Details
Study Description
Brief Summary
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cohort A 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. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. |
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
|
| Active Comparator: Cohort B 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. |
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
|
| Active Comparator: Cohort C 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. |
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
|
Outcome Measures
Primary Outcome Measures
- Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [Baseline, Months 2, 4 and 6.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.
-
Histologically documented adenocarcinoma of the prostate.
-
Metastatic disease.
-
Progressive androgen independent castrate resistant prostate cancer.
-
Serum PSA ≥ 5.0 ng/mL.
-
Life expectancy of ≥ 6 months.
-
Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
-
Men ≥ 18 years of age.
-
Adequate hematologic, renal and liver function.
Exclusion Criteria:
A subject will not be eligible for participation in this study if any of the following criteria apply.
-
The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
-
A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
-
Moderate to severe disease related pain.
-
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
-
Use of non-steroidal antiandrogens within 6 weeks of registration.
-
Anti-androgen withdrawal response.
-
Treatment with chemotherapy within 3 months of registration.
-
More than 2 chemotherapy regimens prior to registration.
-
Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
-
Treatment with any of the following medications or interventions within 28 days of registration:
-
Systemic corticosteroids,
-
External beam radiation therapy or surgery,
-
Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
-
Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
-
5-alpha-reductase inhibitors,
-
High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).
-
Any other systemic therapy for prostate cancer (except for medical castration).
-
Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
-
Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
-
Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
-
A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
-
A requirement for systemic immunosuppressive therapy for any reason.
-
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor.
-
Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
-
Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSD Moores Cancer Center | La Jolla | California | United States | 92093-0820 |
| 2 | Sharp Clinical Oncology Research | San Diego | California | United States | 92123 |
| 3 | Georgetown University Medical Center | Washington, D.C. | District of Columbia | United States | 20007 |
| 4 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 5 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 6 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 7 | Providence Medical Center | Portland | Oregon | United States | 97213 |
| 8 | Kaiser Permanente | Portland | Oregon | United States | 97227 |
| 9 | Northwest Cancer Specialists | Portland | Oregon | United States | 97227 |
| 10 | Urology of Virginia, Sentara Medical Group | Norfolk | Virginia | United States | 23503 |
| 11 | Virginia Mason Medical Center Urology and Renal Transplantation | Seattle | Washington | United States | 98101 |
| 12 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98102 |
Sponsors and Collaborators
- Dendreon
Investigators
- Study Director: Robert Israel, MD, Valeant Pharmaceuticals North America LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Prostate Cancer Research Institute
- National Alliance of State Prostate Cancer Coalitions
- Us TOO International
Publications
None provided.- P07-2
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| 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 Participants | 41 | 40 | 41 | 122 |
| Age (Count of Participants) | ||||
| <=18 years |
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 (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
71.0
(8.25)
|
71.8
(8.29)
|
68.6
(7.5)
|
70.5
(8.07)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
41
100%
|
40
100%
|
41
100%
|
122
100%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
5
12.5%
|
0
0%
|
5
4.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
7.3%
|
0
0%
|
3
7.3%
|
6
4.9%
|
| White |
38
92.7%
|
35
87.5%
|
38
92.7%
|
111
91%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
41
100%
|
40
100%
|
41
100%
|
122
100%
|
| Eastern Cooperative Oncology Group (ECOG) performance status (Count of Participants) | ||||
| ECOG 0=Fully Active; No restrictions |
29
70.7%
|
24
60%
|
27
65.9%
|
80
65.6%
|
| ECOG 1= Restricted Strenuous Activity |
12
29.3%
|
16
40%
|
14
34.1%
|
42
34.4%
|
| Gleason Score (Count of Participants) | ||||
| Gleason Score ≤ 6 |
7
17.1%
|
8
20%
|
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%
|
23
56.1%
|
61
50%
|
| Missing information |
0
0%
|
1
2.5%
|
0
0%
|
1
0.8%
|
Outcome Measures
| Title | Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. |
|---|---|
| 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. |
Outcome Measure Data
| 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 |
|---|---|---|---|
| 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. |
| Measure Participants | 40 | 36 | 37 |
| Mean (Standard Error) [Ratio ofCD54 molecules on BDS65:FP cells] |
29.53
(1.285)
|
30.94
(1.418)
|
26.67
(1.194)
|
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 | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | ratio of geometric means (GeoMean) |
| Estimated Value | 1.046 | |
| Confidence Interval |
(2-Sided) 90% 0.936 to 1.168 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | the ratio of geometric means |
| Estimated Value | 0.907 | |
| Confidence Interval |
(2-Sided) 90% 0.813 to 1.013 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| 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 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/40 (72.5%) | 36/40 (90%) | 36/40 (90%) | |||
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%) | 9/40 (22.5%) | 11/40 (27.5%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 0/40 (0%) | 0 | 3/40 (7.5%) | 3 | 0/40 (0%) | 0 |
| DISSEMINATED INTRAVASCULAR COAGULATION | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Cardiac disorders | ||||||
| ACUTE MYOCARDIAL INFARCTION | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| ANGINA PECTORIS | 0/40 (0%) | 0 | 1/40 (2.5%) | 2 | 0/40 (0%) | 0 |
| ATRIAL FIBRILLATION | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| ATRIOVENTRICULAR BLOCK COMPLETE | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| BRADYCARDIA | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| CARDIAC FAILURE CONGESTIVE | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| CARDIO-RESPIRATORY ARREST | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| CORONARY ARTERY DISEASE | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| VERTIGO | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| Gastrointestinal disorders | ||||||
| ILEUS | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| General disorders | ||||||
| ASTHENIA | 3/40 (7.5%) | 3 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| CHILLS | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| DISEASE PROGRESSION | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 |
| FATIGUE | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| NON-CARDIAC CHEST PAIN | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| PYREXIA | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Infections and infestations | ||||||
| BACTERAEMIA | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| DEVICE RELATED INFECTION | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| PNEUMONIA | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| SEPSIS | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| URINARY TRACT INFECTION | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 |
| UROSEPSIS | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| CERVICAL VERTEBRAL FRACTURE | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| HIP FRACTURE | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 |
| WOUND | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| DEHYDRATION | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 |
| HYPERGLYCAEMIA | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| HYPOCALCAEMIA | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| HYPONATRAEMIA | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| Nervous system disorders | ||||||
| CEREBRAL INFARCTION | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| CEREBROVASCULAR ACCIDENT | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| INTRACRANIAL TUMOUR HAEMORRHAGE | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| SPINAL CORD COMPRESSION | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| SYNCOPE | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| TRANSIENT ISCHAEMIC ATTACK | 0/40 (0%) | 0 | 1/40 (2.5%) | 2 | 1/40 (2.5%) | 1 |
| Psychiatric disorders | ||||||
| CONFUSIONAL STATE | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| Renal and urinary disorders | ||||||
| BLADDER OUTLET OBSTRUCTION | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| HYDRONEPHROSIS | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| RENAL FAILURE ACUTE | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| URETHRAL STENOSIS | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| ACUTE RESPIRATORY FAILURE | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 1/40 (2.5%) | 2 |
| DYSPNOEA | 1/40 (2.5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| HYPOXIA | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Cohort A | Cohort B | Cohort C | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/40 (95%) | 40/40 (100%) | 40/40 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 6/40 (15%) | 6 | 4/40 (10%) | 5 | 8/40 (20%) | 8 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL DISCOMFORT | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| ABDOMINAL PAIN | 4/40 (10%) | 4 | 2/40 (5%) | 3 | 3/40 (7.5%) | 3 |
| ABDOMINAL PAIN UPPER | 2/40 (5%) | 2 | 2/40 (5%) | 2 | 2/40 (5%) | 3 |
| CONSTIPATION | 9/40 (22.5%) | 10 | 8/40 (20%) | 9 | 6/40 (15%) | 7 |
| DIARRHOEA | 4/40 (10%) | 5 | 4/40 (10%) | 4 | 3/40 (7.5%) | 3 |
| DYSPEPSIA | 4/40 (10%) | 4 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| DYSPHAGIA | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| FLATULENCE | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| NAUSEA | 16/40 (40%) | 20 | 11/40 (27.5%) | 11 | 11/40 (27.5%) | 12 |
| RETCHING | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| VOMITING | 8/40 (20%) | 9 | 5/40 (12.5%) | 5 | 5/40 (12.5%) | 6 |
| PARAESTHESIA ORAL | 2/40 (5%) | 4 | 3/40 (7.5%) | 5 | 5/40 (12.5%) | 9 |
| HYPOAESTHESIA ORAL | 3/40 (7.5%) | 3 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| General disorders | ||||||
| ASTHENIA | 2/40 (5%) | 2 | 3/40 (7.5%) | 3 | 4/40 (10%) | 5 |
| CHEST DISCOMFORT | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| CHEST PAIN | 6/40 (15%) | 6 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| CHILLS | 9/40 (22.5%) | 15 | 13/40 (32.5%) | 25 | 10/40 (25%) | 15 |
| FATIGUE | 20/40 (50%) | 23 | 20/40 (50%) | 27 | 16/40 (40%) | 17 |
| INFLUENZA LIKE ILLNESS | 4/40 (10%) | 6 | 0/40 (0%) | 0 | 4/40 (10%) | 6 |
| MALAISE | 1/40 (2.5%) | 2 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| OEDEMA PERIPHERAL | 6/40 (15%) | 6 | 9/40 (22.5%) | 10 | 4/40 (10%) | 5 |
| PAIN | 0/40 (0%) | 0 | 4/40 (10%) | 6 | 1/40 (2.5%) | 1 |
| PYREXIA | 5/40 (12.5%) | 6 | 4/40 (10%) | 5 | 7/40 (17.5%) | 8 |
| Infections and infestations | ||||||
| BRONCHITIS | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| GASTROENTERITIS VIRAL | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| NASOPHARYNGITIS | 3/40 (7.5%) | 3 | 3/40 (7.5%) | 3 | 1/40 (2.5%) | 1 |
| PNEUMONIA | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 2/40 (5%) | 2 |
| UPPER RESPIRATORY TRACT INFECTION | 2/40 (5%) | 3 | 2/40 (5%) | 2 | 2/40 (5%) | 2 |
| URINARY TRACT INFECTION | 2/40 (5%) | 2 | 5/40 (12.5%) | 6 | 1/40 (2.5%) | 1 |
| VIRAL INFECTION | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| CITRATE TOXICITY | 5/40 (12.5%) | 10 | 4/40 (10%) | 7 | 6/40 (15%) | 13 |
| CONTUSION | 3/40 (7.5%) | 3 | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 |
| FALL | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 | 2/40 (5%) | 4 |
| LACERATION | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 2/40 (5%) | 3 |
| Investigations | ||||||
| BLOOD PRESSURE INCREASED | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 | 2/40 (5%) | 7 |
| WEIGHT DECREASED | 7/40 (17.5%) | 7 | 5/40 (12.5%) | 5 | 3/40 (7.5%) | 3 |
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 7/40 (17.5%) | 8 | 10/40 (25%) | 10 | 8/40 (20%) | 8 |
| DEHYDRATION | 8/40 (20%) | 12 | 4/40 (10%) | 8 | 4/40 (10%) | 6 |
| HYPOKALAEMIA | 0/40 (0%) | 0 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| HYPONATRAEMIA | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 11/40 (27.5%) | 16 | 13/40 (32.5%) | 19 | 7/40 (17.5%) | 13 |
| BACK PAIN | 10/40 (25%) | 15 | 16/40 (40%) | 21 | 12/40 (30%) | 16 |
| BONE PAIN | 3/40 (7.5%) | 3 | 0/40 (0%) | 0 | 5/40 (12.5%) | 5 |
| FLANK PAIN | 4/40 (10%) | 5 | 4/40 (10%) | 4 | 1/40 (2.5%) | 1 |
| GROIN PAIN | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| MUSCLE SPASMS | 4/40 (10%) | 4 | 6/40 (15%) | 7 | 2/40 (5%) | 2 |
| MUSCULAR WEAKNESS | 0/40 (0%) | 0 | 3/40 (7.5%) | 3 | 2/40 (5%) | 2 |
| MUSCULOSKELETAL CHEST PAIN | 4/40 (10%) | 4 | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 |
| MUSCULOSKELETAL DISCOMFORT | 1/40 (2.5%) | 1 | 2/40 (5%) | 3 | 0/40 (0%) | 0 |
| MUSCULOSKELETAL PAIN | 8/40 (20%) | 9 | 4/40 (10%) | 5 | 12/40 (30%) | 13 |
| MYALGIA | 7/40 (17.5%) | 8 | 5/40 (12.5%) | 5 | 4/40 (10%) | 5 |
| NECK PAIN | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| PAIN IN EXTREMITY | 6/40 (15%) | 8 | 3/40 (7.5%) | 6 | 9/40 (22.5%) | 9 |
| Nervous system disorders | ||||||
| DIZZINESS | 6/40 (15%) | 7 | 6/40 (15%) | 6 | 8/40 (20%) | 11 |
| DYSGEUSIA | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| HEADACHE | 4/40 (10%) | 5 | 3/40 (7.5%) | 3 | 7/40 (17.5%) | 8 |
| HYPOAESTHESIA | 1/40 (2.5%) | 1 | 5/40 (12.5%) | 11 | 1/40 (2.5%) | 1 |
| PARAESTHESIA | 3/40 (7.5%) | 3 | 9/40 (22.5%) | 12 | 5/40 (12.5%) | 5 |
| RESTLESS LEGS SYNDROME | 1/40 (2.5%) | 1 | 2/40 (5%) | 3 | 2/40 (5%) | 3 |
| SOMNOLENCE | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 1/40 (2.5%) | 1 |
| TREMOR | 2/40 (5%) | 2 | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 |
| Psychiatric disorders | ||||||
| AGITATION | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 2/40 (5%) | 2 |
| ANXIETY | 3/40 (7.5%) | 4 | 6/40 (15%) | 7 | 3/40 (7.5%) | 3 |
| DEPRESSION | 5/40 (12.5%) | 5 | 1/40 (2.5%) | 1 | 3/40 (7.5%) | 3 |
| INSOMNIA | 3/40 (7.5%) | 3 | 5/40 (12.5%) | 5 | 6/40 (15%) | 6 |
| Renal and urinary disorders | ||||||
| HAEMATURIA | 5/40 (12.5%) | 6 | 4/40 (10%) | 6 | 1/40 (2.5%) | 1 |
| HYDRONEPHROSIS | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| NEPHROLITHIASIS | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| NOCTURIA | 2/40 (5%) | 2 | 5/40 (12.5%) | 5 | 2/40 (5%) | 2 |
| POLLAKIURIA | 1/40 (2.5%) | 1 | 4/40 (10%) | 4 | 0/40 (0%) | 0 |
| URINARY RETENTION | 0/40 (0%) | 0 | 3/40 (7.5%) | 3 | 3/40 (7.5%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 4/40 (10%) | 4 | 2/40 (5%) | 2 | 3/40 (7.5%) | 3 |
| DYSPNOEA | 3/40 (7.5%) | 3 | 4/40 (10%) | 4 | 3/40 (7.5%) | 3 |
| DYSPNOEA EXERTIONAL | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 | 3/40 (7.5%) | 3 |
| PRODUCTIVE COUGH | 2/40 (5%) | 2 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| ECCHYMOSIS | 3/40 (7.5%) | 4 | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 |
| HYPERHIDROSIS | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| RASH | 1/40 (2.5%) | 1 | 2/40 (5%) | 2 | 2/40 (5%) | 2 |
| Vascular disorders | ||||||
| HAEMATOMA | 3/40 (7.5%) | 3 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| HOT FLUSH | 1/40 (2.5%) | 1 | 1/40 (2.5%) | 1 | 2/40 (5%) | 3 |
| HYPERTENSION | 3/40 (7.5%) | 6 | 4/40 (10%) | 5 | 2/40 (5%) | 2 |
| HYPOTENSION | 1/40 (2.5%) | 1 | 0/40 (0%) | 0 | 4/40 (10%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Shabnam Vaziri |
|---|---|
| Organization | Dendreon |
| Phone | 206-455-2323 |
| Svaziri@Dendreon.com |
- P07-2