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Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01875250
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ravi A. Madan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Biological: PROSTVAC-F (Fowlpox)/TRICOM
Biological: PROSTVAC-V (Vaccinia)/TRICOM
Drug: Enzalutamide (Xtandi)
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Hide Arm/Group Description

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Period Title: Overall Study
Started 19 19
Completed 17 19
Not Completed 2 0
Reason Not Completed
Adverse Event             2             0
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM Total
Hide Arm/Group Description

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  42.1%
12
  63.2%
20
  52.6%
>=65 years
11
  57.9%
7
  36.8%
18
  47.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
65.7  (8.46) 66.07  (5.29) 65.88  (6.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
19
 100.0%
19
 100.0%
38
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
19
 100.0%
38
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  21.1%
3
  15.8%
7
  18.4%
White
15
  78.9%
16
  84.2%
31
  81.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Tumor Growth Rate
Hide Description Growth rate was measured using the growth rate equation -f(t) = exp (-d*t) + exp (g*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Hide Arm/Group Description:

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: unitless
0.031 0.030
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A - Enzalutamide for 3 Months, Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Wilcoxon rank sum tests
Comments [Not Specified]
2.Secondary Outcome
Title Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide
Hide Description VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) assay. The lower limit of quantitation of assay was 9.0 pg/ml.
Time Frame 30 Days After the Start of Course 1 and Course 2 of Enzalutamide
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine analysis for Arms of growth factors.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: pg/ml
Course 1 192  (82)
Course 2 165.04  (82.38)
3.Secondary Outcome
Title Median Testosterone After 84 Days of Enzalutamide
Hide Description Normal testosterone is 270-1070 nd/dL.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine analysis for testosterone. In addition, data was not analyzed beyond Course 1 because it was not part of the initial statistical plan.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM,
Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: ng/dl
834
(308 to 1579)
4.Secondary Outcome
Title Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1
Hide Description Median PSA change would be considered optimal.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Hide Arm/Group Description:

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: Percent change
-99
(-84 to -99)
-99
(-87 to -99)
5.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Hide Arm/Group Description:

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
19
 100.0%
19
 100.0%
6.Secondary Outcome
Title Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide
Hide Description PSA recovery is defined as the return above baseline PSA in participants with normal testosterone and non-metastatic, castration sensitive prostate cancer.
Time Frame up to 41 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine analysis for Arms of PSA Recovery time.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM.
Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: Days
Course 1
224
(84 to 1246)
Course 2
189
(78 to 400)
Time Frame Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Hide Arm/Group Description

Enzalutamide for 3 months

Enzalutamide (Xtandi): An androgen receptor inhibitor.

Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21

PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.

Enzalutamide (Xtandi): An androgen receptor inhibitor.

All-Cause Mortality
Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/19 (5.26%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [1]  0/19 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Surgical biopsy 1/5 and 6 weeks of radiation scheduled to start January 2017.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A - Enzalutamide for 3 Months Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  5/19 (26.32%)  6 8/19 (42.11%)  11
Blood and lymphatic system disorders - Other, specify  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Thrombotic thrombocytopenic purpura  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Cardiac disorders - Other, specify  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Chest pain - cardiac  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Palpitations  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Ear and labyrinth disorders     
Ear pain  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Eye disorders     
Blurred vision  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Cataract  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Eye disorders - Other, Diplopia Lightheadedness intermittent  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Eye disorders - Other, Tearfullness  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Flashing lights  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/19 (5.26%)  1 1/19 (5.26%)  2
Bloating  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Constipation  1  1/19 (5.26%)  2 5/19 (26.32%)  6
Diarrhea  1  3/19 (15.79%)  3 5/19 (26.32%)  5
Dry mouth  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Dysphagia  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Esophageal obstruction  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Gastroesophageal reflux disease  1  1/19 (5.26%)  1 1/19 (5.26%)  2
Gastrointestinal disorders - Other, Damaged broken tooth  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrointestinal disorders - Other, Reflux  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Mucositis oral  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nausea  1  7/19 (36.84%)  8 4/19 (21.05%)  7
Rectal hemorrhage  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Stomach pain  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Toothache  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Vomiting  1  2/19 (10.53%)  2 2/19 (10.53%)  3
General disorders     
Chills  1  2/19 (10.53%)  2 3/19 (15.79%)  7
Edema limbs  1  5/19 (26.32%)  6 2/19 (10.53%)  2
Fatigue  1  16/19 (84.21%)  26 16/19 (84.21%)  28
Fever  1  0/19 (0.00%)  0 1/19 (5.26%)  3
Flatulence  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Flu like symptoms  1  1/19 (5.26%)  1 6/19 (31.58%)  7
Injection site reaction  1  0/19 (0.00%)  0 18/19 (94.74%)  70
Pain  1  4/19 (21.05%)  6 5/19 (26.32%)  7
Immune system disorders     
Autoimmune disorder  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations     
Bronchial infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Eye infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Gum infection  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations - Diverticulitis-received 2 antibiotics  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, Flu 2-3 weeks ago,  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, No antibiotics  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, URI and rash  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, URI-head cold, uses Dayquil  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, UTI  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, Viral infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, Wound infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations - Other, Cold  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations - Other, Cold- OTC meds  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations - Other, Erythema  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations - Other, Fungal infection-Terbinafine  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations - Other, URI- no antibiotics  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Lip infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Rhinitis infective  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Sinusitis  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Upper respiratory infection  1  3/19 (15.79%)  3 5/19 (26.32%)  5
Injury, poisoning and procedural complications     
Fall  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Fracture  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Investigations     
Alanine aminotransferase increased  1  5/19 (26.32%)  9 5/19 (26.32%)  8
Aspartate aminotransferase increased  1  3/19 (15.79%)  6 2/19 (10.53%)  6
Blood bilirubin increased  1  1/19 (5.26%)  1 0/19 (0.00%)  0
CPK increased  1  4/19 (21.05%)  10 4/19 (21.05%)  5
Cholesterol high  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Creatinine increased  1  2/19 (10.53%)  2 2/19 (10.53%)  2
Lymphocyte count decreased  1  7/19 (36.84%)  15 8/19 (42.11%)  22
Neutrophil count decreased  1  1/19 (5.26%)  3 2/19 (10.53%)  4
Platelet count decreased  1  2/19 (10.53%)  2 4/19 (21.05%)  9
Weight gain  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Weight loss  1  1/19 (5.26%)  1 2/19 (10.53%)  2
White blood cell decreased  1  5/19 (26.32%)  9 8/19 (42.11%)  12
Metabolism and nutrition disorders     
Anorexia  1  3/19 (15.79%)  4 4/19 (21.05%)  5
Hypercalcemia  1  1/19 (5.26%)  1 2/19 (10.53%)  3
Hyperglycemia  1  9/19 (47.37%)  26 8/19 (42.11%)  14
Hyperkalemia  1  1/19 (5.26%)  1 1/19 (5.26%)  2
Hypernatremia  1  4/19 (21.05%)  6 3/19 (15.79%)  3
Hypoalbuminemia  1  1/19 (5.26%)  3 2/19 (10.53%)  3
Hypocalcemia  1  0/19 (0.00%)  0 1/19 (5.26%)  2
Hypoglycemia  1  2/19 (10.53%)  3 2/19 (10.53%)  3
Hypokalemia  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Hyponatremia  1  3/19 (15.79%)  3 2/19 (10.53%)  3
Hypophosphatemia  1  9/19 (47.37%)  26 7/19 (36.84%)  24
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Back pain  1  4/19 (21.05%)  4 8/19 (42.11%)  12
Buttock pain  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Joint range of motion decreased  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Muscle weakness lower limb  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Muscle weakness upper limb  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Myalgia  1  3/19 (15.79%)  3 7/19 (36.84%)  7
Neck pain  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Pain in extremity  1  2/19 (10.53%)  2 2/19 (10.53%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Nervous system disorders     
Concentration impairment  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Depressed level of consciousness  1  0/19 (0.00%)  0 1/19 (5.26%)  2
Dizziness  1  5/19 (26.32%)  10 5/19 (26.32%)  7
Dysgeusia  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Facial nerve disorder  1  0/19 (0.00%)  0 1/19 (5.26%)  2
Headache  1  2/19 (10.53%)  2 6/19 (31.58%)  13
Lethargy  1  3/19 (15.79%)  4 4/19 (21.05%)  4
Memory impairment  1  1/19 (5.26%)  1 3/19 (15.79%)  3
Nervous system disorders - Other, specify  1  1/19 (5.26%)  2 0/19 (0.00%)  0
Paresthesia  1  1/19 (5.26%)  1 2/19 (10.53%)  2
Peripheral sensory neuropathy  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Somnolence  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Tremor  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Psychiatric disorders     
Anxiety  1  1/19 (5.26%)  2 3/19 (15.79%)  3
Depression  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Insomnia  1  1/19 (5.26%)  2 3/19 (15.79%)  3
Renal and urinary disorders     
Hematuria  1  1/19 (5.26%)  1 3/19 (15.79%)  3
Hemoglobinuria  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Urinary frequency  1  3/19 (15.79%)  3 6/19 (31.58%)  6
Urinary incontinence  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Urinary retention  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Urinary tract obstruction  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Urinary tract pain  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Urine discoloration  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders     
Breast atrophy  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Breast pain  1  15/19 (78.95%)  19 16/19 (84.21%)  21
Erectile dysfunction  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Gynecomastia  1  9/19 (47.37%)  13 7/19 (36.84%)  8
Libido decreased  1  1/19 (5.26%)  1 3/19 (15.79%)  4
Nipple deformity  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  3/19 (15.79%)  3 2/19 (10.53%)  2
Cough  1  4/19 (21.05%)  5 2/19 (10.53%)  2
Hoarseness  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Nasal congestion  1  2/19 (10.53%)  2 1/19 (5.26%)  1
Pharyngolaryngeal pain  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Sneezing  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Sore throat  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Voice alteration  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Dermatitis radiation  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Dry skin  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Erythema multiforme  1  0/19 (0.00%)  0 2/19 (10.53%)  2
Pruritus  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Rash acneiform  1  1/19 (5.26%)  2 0/19 (0.00%)  0
Rash maculo-papular  1  1/19 (5.26%)  2 2/19 (10.53%)  3
Skin and subcutaneous tissue disorders - Other, Dry skin  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Fullness B/L in temporal area-not painful  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Pre cancerous lesion  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sores on feet  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Abraasion  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders - Other, Allergic reaction  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders - Other, Callus  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders - Other, Cold sore  1  0/19 (0.00%)  0 1/19 (5.26%)  2
Skin and subcutaneous tissue disorders - Other, Dry skin  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Vascular disorders     
Hot flashes  1  3/19 (15.79%)  4 3/19 (15.79%)  4
Hypertension  1  2/19 (10.53%)  2 1/19 (5.26%)  1
Hypotension  1  1/19 (5.26%)  1 1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ravi A. Madan
Organization: National Cancer Institute
Phone: 301-480-7168
EMail: m480i@nih.gov
Layout table for additonal information
Responsible Party: Ravi A. Madan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01875250    
Other Study ID Numbers: 130153
13-C-0153
First Submitted: June 7, 2013
First Posted: June 11, 2013
Results First Submitted: August 13, 2020
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020