Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00974311
First received: September 9, 2009
Last updated: February 22, 2014
Last verified: February 2014
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Castration-Resistant Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter, global clinical trial

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized 2:1 to receive either Enzalutamide or placebo

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Participant Flow:   Overall Study
    Enzalutamide     Placebo  
STARTED     800     399  
COMPLETED     254 [1]   163 [1]
NOT COMPLETED     546     236  
Lost to Follow-up                 1                 1  
Death                 305                 211  
Withdrawal of consent                 9                 5  
Continuing Treatment                 231                 19  
[1] Indicates participants continuing long-term follow-up as of 25 September 2011.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Total Total of all reporting groups

Baseline Measures
    Enzalutamide     Placebo     Total  
Number of Participants  
[units: participants]
  800     399     1199  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     232     130     362  
>=65 years     568     269     837  
Age  
[units: years]
Mean ± Standard Deviation
  68.8  ± 7.96     68.6  ± 8.39     68.7  ± 8.11  
Gender  
[units: participants]
     
Female     0     0     0  
Male     800     399     1199  
Region of Enrollment  
[units: participants]
     
United States     181     107     288  
Spain     23     13     36  
Austria     15     10     25  
Chile     6     5     11  
United Kingdom     82     50     132  
Italy     20     10     30  
France     193     80     273  
Canada     82     25     107  
Argentina     7     3     10  
Belgium     27     18     45  
Poland     7     4     11  
Australia     60     33     93  
South Africa     3     3     6  
Germany     62     24     86  
Netherlands     32     14     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: During study period (up to 3 years) ]

2.  Secondary:   Radiographic Progression-free Survival   [ Time Frame: During study period (up to 3 years) ]

3.  Secondary:   Time to First Skeletal-related Event   [ Time Frame: During study period (up to 3 years) ]

4.  Secondary:   Functional Assessment of Cancer Therapy - Prostate (FACT-P)   [ Time Frame: During study period (up to 3 years) ]

5.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Baseline and at every study visit from week 13 while on study drug (up to 3 years) ]

6.  Secondary:   Percentage of Patients With Pain Palliation   [ Time Frame: During study period (up to 3 years) ]

7.  Secondary:   Percentage of Patients With Prostate Specific Antigen (PSA) Response   [ Time Frame: During study period (up to 3 years) ]

8.  Secondary:   Percentage of Patients With Soft-tissue Objective Response   [ Time Frame: During study period (up to 3 years) ]

9.  Secondary:   European Quality of Life Five-Domain Scale (EQ-5D)   [ Time Frame: At Week 13 visit ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No

10.  Secondary:   Circulating Tumor Cell (CTC) Conversion Rate   [ Time Frame: During study period (up to 3 years) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Other Adverse Events
    Enzalutamide     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     785/800     390/399  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     106/800 (13.25%)     70/399 (17.54%)  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     263/800 (32.88%)     166/399 (41.60%)  
Constipation † 1    
# participants affected / at risk     187/800 (23.38%)     108/399 (27.07%)  
Diarrhoea † 1    
# participants affected / at risk     168/800 (21.00%)     70/399 (17.54%)  
Vomiting † 1    
# participants affected / at risk     129/800 (16.13%)     84/399 (21.05%)  
Abdominal pain † 1    
# participants affected / at risk     40/800 (5.00%)     21/399 (5.26%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     269/800 (33.63%)     113/399 (28.32%)  
Asthenia † 1    
# participants affected / at risk     138/800 (17.25%)     66/399 (16.54%)  
Oedema peripheral † 1    
# participants affected / at risk     119/800 (14.88%)     50/399 (12.53%)  
Pyrexia † 1    
# participants affected / at risk     53/800 (6.63%)     23/399 (5.76%)  
Infections and infestations      
Urinary tract infection † 1    
# participants affected / at risk     59/800 (7.38%)     24/399 (6.02%)  
Investigations      
Weight decreased † 1    
# participants affected / at risk     94/800 (11.75%)     41/399 (10.28%)  
Metabolism and nutrition disorders      
Anorexia † 1    
# participants affected / at risk     200/800 (25.00%)     104/399 (26.07%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     190/800 (23.75%)     90/399 (22.56%)  
Arthralgia † 1    
# participants affected / at risk     153/800 (19.13%)     71/399 (17.79%)  
Pain in extremity † 1    
# participants affected / at risk     118/800 (14.75%)     62/399 (15.54%)  
Bone pain † 1    
# participants affected / at risk     104/800 (13.00%)     65/399 (16.29%)  
Musculoskeletal pain † 1    
# participants affected / at risk     109/800 (13.63%)     40/399 (10.03%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     63/800 (7.88%)     34/399 (8.52%)  
Muscular weakness † 1    
# participants affected / at risk     66/800 (8.25%)     27/399 (6.77%)  
Myalgia † 1    
# participants affected / at risk     49/800 (6.13%)     26/399 (6.52%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     93/800 (11.63%)     21/399 (5.26%)  
Dizziness † 1    
# participants affected / at risk     54/800 (6.75%)     21/399 (5.26%)  
Paraesthesia † 1    
# participants affected / at risk     52/800 (6.50%)     18/399 (4.51%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     69/800 (8.63%)     24/399 (6.02%)  
Anxiety † 1    
# participants affected / at risk     51/800 (6.38%)     16/399 (4.01%)  
Depression † 1    
# participants affected / at risk     43/800 (5.38%)     18/399 (4.51%)  
Renal and urinary disorders      
Haematuria † 1    
# participants affected / at risk     46/800 (5.75%)     14/399 (3.51%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea † 1    
# participants affected / at risk     78/800 (9.75%)     38/399 (9.52%)  
Cough † 1    
# participants affected / at risk     47/800 (5.88%)     25/399 (6.27%)  
Vascular disorders      
Hot flush † 1    
# participants affected / at risk     162/800 (20.25%)     41/399 (10.28%)  
Hypertension † 1    
# participants affected / at risk     49/800 (6.13%)     11/399 (2.76%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information