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A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

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ClinicalTrials.gov Identifier: NCT01534052
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : April 27, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Castration-Resistant Prostate Cancer (CRPC)
Intervention Drug: Enzalutamide
Enrollment 52
Recruitment Details The study was conducted at 1 site in the Republic of Moldova, 2 sites in South Africa and 4 sites in the United States. In order to participate, participants had to complete a prior study with enzalutamide, be in a state of at least stable disease and benefit from continued treatment with enzalutamide in the opinion of the investigator.
Pre-assignment Details This was an extension study in prostate cancer participants who have received enzalutamide treatment in prior phase 1 studies. The 9785-CL-0121 was an extension of previous enzalutamide studies (9785-CL-0003 [NCT01902251], 9785-CL-0007 [NCT01911728] & 9785-CL-0406 [NCT02225093]).
Arm/Group Title Enzalutamide
Hide Arm/Group Description Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
Period Title: Overall Study
Started 52
Treatment Received 52
Completed 52
Not Completed 0
Arm/Group Title Enzalutamide
Hide Arm/Group Description Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
The analysis population was the Safety Analysis Set (SAF), which consisted of participants who received at least one dose of enzalutamide during the extension study. This extension study’s baseline was considered the original baseline from the prior parent studies with enzalutamide.
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants
68.6  (7.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
0
   0.0%
Male
52
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
52
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   3.8%
White
47
  90.4%
More than one race
0
   0.0%
Unknown or Not Reported
3
   5.8%
Duration of Prostate Cancer   [1] 
Geometric Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 52 participants
69.4  (64.10)
[1]
Measure Description: The duration of prostate cancer was calculated as (Date of first enzalutamide intake in the parent study – Date of initial diagnosis) + 1.
Primary Gleason Score at Initial Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Score 3
15
  28.8%
Score 4
13
  25.0%
Score 5
4
   7.7%
Unknown
20
  38.5%
[1]
Measure Description: Gleason score was a grading system for prostate cancer tissue based on how it looks under a microscope. Gleason scores ranged from 2 to 10 and indicated how likely it was that a tumor will spread. A low Gleason score meant the cancer tissue is similar to normal prostate tissue and the tumor was less likely to spread; a high Gleason score meant the cancer tissue was very different from normal and the tumor was more likely to spread.
Secondary Gleason Score at Initial Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Score 3
9
  17.3%
Score 4
14
  26.9%
Score 5
9
  17.3%
Unknown
20
  38.5%
[1]
Measure Description: Gleason score was a grading system for prostate cancer tissue based on how it looks under a microscope. Gleason scores ranged from 2 to 10 and indicated how likely it was that a tumor will spread. A low Gleason score meant the cancer tissue is similar to normal prostate tissue and the tumor was less likely to spread; a high Gleason score meant the cancer tissue was very different from normal and the tumor was more likely to spread.
Total Gleason Score at Initial Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Score 6
5
   9.6%
Score 7
16
  30.8%
Score 8
1
   1.9%
Score 9
13
  25.0%
Unknown
17
  32.7%
[1]
Measure Description: Gleason score was a grading system for prostate cancer tissue based on how it looks under a microscope. Gleason scores ranged from 2 to 10 and indicated how likely it was that a tumor will spread. A low Gleason score meant the cancer tissue is similar to normal prostate tissue and the tumor was less likely to spread; a high Gleason score meant the cancer tissue was very different from normal and the tumor was more likely to spread.
Primary Tumor Assessment at Initial Diagnosis – Clinical Tumor Stage (T)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
TX – Primary Tumor Cannot be Assessed
3
   5.8%
T0 – No Evidence of Primary Tumor
1
   1.9%
T1 – Clinically Tumor Not Palpable or Visible
1
   1.9%
T2 – Tumor Confined Within the Prostate
8
  15.4%
T3 – Tumor Extends Through the Prostatic Capsule
13
  25.0%
T4 – Tumor Fixed or Invades Adjacent Structures
3
   5.8%
Unknown
23
  44.2%
Pathologic Tumor Stage (pT)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
pT2 – Organ Confined
5
   9.6%
pT3 – Extraprostatic Extension
9
  17.3%
pT4 – Invasion of Bladder, Rectum
1
   1.9%
Unknown
37
  71.2%
Regional Lymph Nodes (N) at Initial Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
NX – Regional Lymph Nodes Were Not Assessed
18
  34.6%
N0 – No Regional Lymph Node Metastasis
15
  28.8%
N1 – Metastasis in Regional Lymph Node(s)
6
  11.5%
pNX – Regional Lymph Nodes Not Sampled
8
  15.4%
pN0 – No Positive Regional Nodes
6
  11.5%
pN1 – Metastasis in Regional Nodes(s)
2
   3.8%
Unknown
36
  69.2%
Distant Metastasis at Initial Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
MX – Distant Metastasis Cannot be Assessed
8
  15.4%
M0 – No Distant Metastasis
12
  23.1%
M1 – Distant Metastasis
9
  17.3%
Unknown
23
  44.2%
Treatment Duration in Extension Study   [1] 
Measure Type: Number
Unit of measure:  Days
Number Analyzed 52 participants
<= 60 4
> 60 – <182 12
>= 182 – <365 9
>= 365 27
[1]
Measure Description: Treatment duration in the extension study was calculated as (Date of last dose of MDV3100 – Date of first dose of MDV3100 in the extension study)+ 1.
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.
Time Frame From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the SAF.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
Overall Number of Participants Analyzed 52
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
43
  82.7%
Drug-Related TEAEs
27
  51.9%
Deaths
5
   9.6%
Serious TEAEs
17
  32.7%
Drug-Related Serious TEAEs
5
   9.6%
TEAEs Leading to Study Drug Discontinuation
12
  23.1%
Drug-Related TEAEs Lead to Study Discontinuation
5
   9.6%
Time Frame From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
Adverse Event Reporting Description The total number of deaths (all causes) includes deaths reported after the time frame above.
 
Arm/Group Title Enzalutimide
Hide Arm/Group Description Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
All-Cause Mortality
Enzalutimide
Affected / at Risk (%)
Total   2/52 (3.85%)    
Show Serious Adverse Events Hide Serious Adverse Events
Enzalutimide
Affected / at Risk (%) # Events
Total   17/52 (32.69%)    
Cardiac disorders   
Acute myocardial infarction  1  1/52 (1.92%)  1
Atrial fibrillation  1  1/52 (1.92%)  1
Tachycardia  1  1/52 (1.92%)  1
Gastrointestinal disorders   
Anal fissure  1  1/52 (1.92%)  1
Diarrhoea  1  1/52 (1.92%)  1
Pancreatitis acute  1  1/52 (1.92%)  1
Proctalgia  1  1/52 (1.92%)  1
Rectal haemorrhage  1  1/52 (1.92%)  1
General disorders   
Asthenia  1  2/52 (3.85%)  2
Infections and infestations   
Pneumonia  1  1/52 (1.92%)  1
Injury, poisoning and procedural complications   
Femur fracture  1  1/52 (1.92%)  1
Hip fracture  1  1/52 (1.92%)  1
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/52 (1.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant neoplasm progression  1  4/52 (7.69%)  4
Pancreatic carcinoma  1  1/52 (1.92%)  1
Tonsil cancer  1  1/52 (1.92%)  1
Nervous system disorders   
Cerebrovascular accident  1  1/52 (1.92%)  1
Dysarthria  1  1/52 (1.92%)  1
Hemiparesis  1  1/52 (1.92%)  1
Spinal cord compression  1  2/52 (3.85%)  2
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/52 (1.92%)  1
Vascular disorders   
Hypertensive crisis  1  1/52 (1.92%)  1
Hypotension  1  1/52 (1.92%)  1
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enzalutimide
Affected / at Risk (%) # Events
Total   33/52 (63.46%)    
Blood and lymphatic system disorders   
Anaemia  1  4/52 (7.69%)  6
Gastrointestinal disorders   
Constipation  1  5/52 (9.62%)  7
Diarrhoea  1  5/52 (9.62%)  8
Dyspepsia  1  3/52 (5.77%)  3
Nausea  1  4/52 (7.69%)  4
Vomiting  1  3/52 (5.77%)  4
General disorders   
Fatigue  1  14/52 (26.92%)  21
Investigations   
Weight decreased  1  4/52 (7.69%)  4
Metabolism and nutrition disorders   
Decreased appetite  1  6/52 (11.54%)  6
Hyperglycaemia  1  4/52 (7.69%)  4
Hypoalbuminaemia  1  4/52 (7.69%)  9
Hyponatraemia  1  5/52 (9.62%)  6
Hypophosphataemia  1  4/52 (7.69%)  8
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/52 (13.46%)  7
Back pain  1  7/52 (13.46%)  8
Bone pain  1  3/52 (5.77%)  3
Muscular weakness  1  4/52 (7.69%)  7
Musculoskeletal pain  1  3/52 (5.77%)  3
Nervous system disorders   
Headache  1  3/52 (5.77%)  4
Renal and urinary disorders   
Pollakiuria  1  3/52 (5.77%)  3
Urinary incontinence  1  3/52 (5.77%)  3
Vascular disorders   
Hot flush  1  6/52 (11.54%)  8
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
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.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. The sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Results Point of Contact
Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Europe B.V. (APEB)
Phone: 800-888-7704 Ext:5473
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01534052     History of Changes
Other Study ID Numbers: 9785-CL-0121
First Submitted: February 8, 2012
First Posted: February 16, 2012
Results First Submitted: March 26, 2018
Results First Posted: April 27, 2018
Last Update Posted: October 4, 2018