ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast 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: NCT01889238
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Results First Posted : August 22, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Intervention Drug: Enzalutamide
Enrollment 118

Recruitment Details  
Pre-assignment Details Data reported based on primary analysis date (01 March 2015)
Arm/Group Title Enzalutamide
Hide Arm/Group Description Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression (DP), intolerable adverse events (AEs) (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Period Title: Overall Study
Started 118
Completed 109 [1]
Not Completed 9
Reason Not Completed
Treatment ongoing             9
[1]
DP, AE, death, treatment withdrawal were considered completed (defined in protocol).
Arm/Group Title Enzalutamide
Hide Arm/Group Description Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Baseline Participants 118
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants who had positive androgen receptor (AR+) breast cancer as assessed by central review and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 118 participants
58.3  (12.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
Female
118
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
Hide Description Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >= 16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(25.53 to 41.63)
2.Primary Outcome
Title Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population
Hide Description Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
24.6
(18.98 to 30.88)
3.Secondary Outcome
Title Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population
Hide Description Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
28.2
(21.04 to 36.48)
4.Secondary Outcome
Title Percentage of Participants With Clinical Benefit at Week 24: ITT Population
Hide Description Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
20.3
(15.16 to 26.21)
5.Secondary Outcome
Title Percentage of Participants With Best Objective Response: Evaluable Population
Hide Description Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
Time Frame From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on participants from Evaluable population who had measurable disease.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 59
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
8.5
(3.05 to 12.02)
6.Secondary Outcome
Title Percentage of Participants With Best Objective Response: ITT Population
Hide Description Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
Time Frame From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on participants from ITT population who had measurable disease.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 97
Measure Type: Number
Number (85% Confidence Interval)
Unit of Measure: percentage of participants
6.2
(2.80 to 8.95)
7.Secondary Outcome
Title Progression-Free Survival (PFS): Evaluable Population
Hide Description PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
Time Frame From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 78
Median (85% Confidence Interval)
Unit of Measure: weeks
14.3
(8.3 to 16.1)
8.Secondary Outcome
Title Progression-Free Survival: ITT Population
Hide Description PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
Time Frame From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Median (85% Confidence Interval)
Unit of Measure: weeks
12.6
(8.1 to 15.1)
9.Other Pre-specified Outcome
Title Trough Plasma Concentration of Enzalutamide and Its Metabolite,
Hide Description M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/ml) for enzalutamide and M2.
Time Frame Predose on Day 1 (Baseline), Week 9 and Week 17
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) analysis population included all participants who received 1 dose or partial dose of study drug, and who had at least 1 enzalutamide or M2 plasma concentration assessment.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 115
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/ml
Enzalutamide: Day 1
NA [1] 
(NA%)
M2: Day 1
NA [1] 
(NA%)
Enzalutamide: Week 9
12.59
(33.46%)
M2: Week 9
13.48
(35.64%)
Enzalutamide: Week 17
12.79
(37.33%)
M2: Week 17
13.88
(25.47%)
[1]
None of the participants had data above LLQ and as per the predefined protocol, values below the limit of quatitation (BLQ) were set to missing and hence not reported.
10.Other Pre-specified Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AEs was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 87 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Time Frame Baseline up to 87 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive 1 dose or partial dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Events
109
  92.4%
Serious Adverse Events
29
  24.6%
11.Other Pre-specified Outcome
Title Number of Participants With Study Drug Discontinuation Due to Adverse Events
Hide Description [Not Specified]
Time Frame Baseline up to 87 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive 1 dose or partial dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
8
   6.8%
12.Other Pre-specified Outcome
Title Number of Participants With Grade 3 or Higher Adverse Events
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure.
Time Frame Baseline up to 87 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive 1 dose or partial dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
36
  30.5%
13.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit or 2 consecutive visits SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 subject had data were reported.
Time Frame Baseline up to 87 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive 1 dose or partial dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
SBP: absolute SBP <90 mmHg and DFB>30 mmHg
1
   0.8%
SBP: FV or 2 CV SBP>=20 mmHg CFB
9
   7.6%
SBP: Most extreme post baseline SBP >=140 mmHg
36
  30.5%
SBP: Most extreme post baseline SBP >=180 mmHg
1
   0.8%
SBP:Most extreme SBP>=140 mmHg and>=20 mmHg CFB
11
   9.3%
DBP: FV or 2 CV DBP>=15 mmHg CFB
10
   8.5%
DBP: Most extreme post baseline result >=90 mmHg
22
  18.6%
DBP: Most extreme post baseline result >=105 mmHg
4
   3.4%
DBP:Most extreme DBP>=105 mmHg and>=15 mmHg CFB
2
   1.7%
DBP:Most extreme DBP>=90 mmHg and>=15 mmHg CFB
12
  10.2%
14.Other Pre-specified Outcome
Title Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades
Hide Description Laboratory tests included hematology parameters (low lymphocytes, WBC, neutrophils, hemoglobin and platelets) and chemistry parameters (mean albumin, Blood urea nitrogen [BUN], calcium, Lactate dehydrogenase [LDH], alanine aminotransferase, Aspartate aminotransferase , bilirubin, Alkaline phosphatase, creatinine and glucose). Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per National Cancer Institute Common Terminology Criteria (NCI CTC) (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.
Time Frame Baseline up to 87 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive 1 dose or partial dose of study drug.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin
1
   0.8%
Leukocytes
4
   3.4%
Lymphocytes
12
  10.2%
Neutrophils
2
   1.7%
Platelets
1
   0.8%
Alanine aminotransferase
1
   0.8%
Albumin
4
   3.4%
Alkaline phosphatase
3
   2.5%
Bilirubin
2
   1.7%
Calcium
2
   1.7%
Glucose
5
   4.2%
Phosphate
4
   3.4%
Time Frame Baseline up to 87 weeks
Adverse Event Reporting Description Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
 
Arm/Group Title Enzalutamide
Hide Arm/Group Description Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
All-Cause Mortality
Enzalutamide
Affected / at Risk (%)
Total   12/118 (10.17%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enzalutamide
Affected / at Risk (%)
Total   29/118 (24.58%) 
Cardiac disorders   
Pericardial effusion * 1  2/118 (1.69%) 
Myocardial infarction * 1  1/118 (0.85%) 
Gastrointestinal disorders   
Constipation * 1  2/118 (1.69%) 
Nausea * 1  1/118 (0.85%) 
General disorders   
Disease progression * 1  3/118 (2.54%) 
General physical health deterioration * 1  1/118 (0.85%) 
Pain * 1  1/118 (0.85%) 
Hepatobiliary disorders   
Bile duct obstruction * 1  1/118 (0.85%) 
Infections and infestations   
Lung infection * 1  2/118 (1.69%) 
Sepsis * 1  2/118 (1.69%) 
Cellulitis * 1  1/118 (0.85%) 
Device related infection * 1  1/118 (0.85%) 
Respiratory tract infection * 1  1/118 (0.85%) 
Soft tissue infection * 1  1/118 (0.85%) 
Injury, poisoning and procedural complications   
Hip fracture * 1  1/118 (0.85%) 
Radiation oesophagitis * 1  1/118 (0.85%) 
Spinal compression fracture * 1  1/118 (0.85%) 
Toxicity to various agents * 1  1/118 (0.85%) 
Traumatic fracture * 1  1/118 (0.85%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/118 (0.85%) 
Hypercalcaemia * 1  1/118 (0.85%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain * 1  1/118 (0.85%) 
Pathological fracture * 1  1/118 (0.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant pleural effusion * 1  3/118 (2.54%) 
Metastatic pain * 1  3/118 (2.54%) 
Breast cancer metastatic * 1  2/118 (1.69%) 
Pericardial effusion malignant * 1  1/118 (0.85%) 
Invasive ductal breast carcinoma * 1  1/118 (0.85%) 
Malignant neoplasm progression * 1  1/118 (0.85%) 
Metastases to central nervous system * 1  1/118 (0.85%) 
Metastases to lung * 1  1/118 (0.85%) 
Nervous system disorders   
Spinal cord compression * 1  2/118 (1.69%) 
Cognitive disorder * 1  1/118 (0.85%) 
Renal and urinary disorders   
Renal failure acute * 1  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  3/118 (2.54%) 
Pleuritic pain * 1  1/118 (0.85%) 
Respiratory failure * 1  1/118 (0.85%) 
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enzalutamide
Affected / at Risk (%)
Total   100/118 (84.75%) 
Gastrointestinal disorders   
Nausea * 1  40/118 (33.90%) 
Diarrhoea * 1  18/118 (15.25%) 
Constipation * 1  18/118 (15.25%) 
Vomiting * 1  11/118 (9.32%) 
Abdominal pain * 1  7/118 (5.93%) 
General disorders   
Fatigue * 1  49/118 (41.53%) 
Pain * 1  9/118 (7.63%) 
Asthenia * 1  6/118 (5.08%) 
Infections and infestations   
Nasopharyngitis * 1  6/118 (5.08%) 
Upper respiratory tract infection * 1  6/118 (5.08%) 
Investigations   
Weight decreased * 1  8/118 (6.78%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  22/118 (18.64%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  17/118 (14.41%) 
Arthralgia * 1  17/118 (14.41%) 
Pain in extremity * 1  9/118 (7.63%) 
Musculoskeletal pain * 1  10/118 (8.47%) 
Muscle spasms * 1  6/118 (5.08%) 
Nervous system disorders   
Headache * 1  17/118 (14.41%) 
Dizziness * 1  6/118 (5.08%) 
Neuropathy peripheral * 1  6/118 (5.08%) 
Psychiatric disorders   
Insomnia * 1  17/118 (14.41%) 
Anxiety * 1  7/118 (5.93%) 
Reproductive system and breast disorders   
Breast pain * 1  6/118 (5.08%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  13/118 (11.02%) 
Cough * 1  7/118 (5.93%) 
Vascular disorders   
Hot flush * 1  12/118 (10.17%) 
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-systematic assessment
As per change in planned analysis, AR low population (all enrolled participants who had AR nuclear staining > 0%, < 10% assessed centrally) was not analyzed for efficacy and duration of response, time to response were not analyzed for any population
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01889238     History of Changes
Other Study ID Numbers: MDV3100-11
2013-000698-57 ( EudraCT Number )
C3431007 ( Other Identifier: Alias Study Number )
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: July 26, 2018
Results First Posted: August 22, 2018
Last Update Posted: October 23, 2018