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A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)

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ClinicalTrials.gov Identifier: NCT01946204
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: Apalutamide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Apalutamide Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.

Participant Flow:   Overall Study
    Placebo   Apalutamide
STARTED   401   806 
Treated   398   803 
COMPLETED   0   0 
NOT COMPLETED   401   806 
Death                38                59 
Withdrawal by Subject                37                50 
Lost to Follow-up                3                7 
Ongoing                316                687 
Other                7                3 



  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
Placebo Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Apalutamide Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Total Total of all reporting groups

Baseline Measures
   Placebo   Apalutamide   Total 
Overall Participants Analyzed 
[Units: Participants]
 401   806   1207 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.1  (7.92)   73.7  (8.07)   73.9  (8.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      401 100.0%      806 100.0%      1207 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   1.2%      11   1.4%      16   1.3% 
Not Hispanic or Latino      338  84.3%      659  81.8%      997  82.6% 
Unknown or Not Reported      58  14.5%      136  16.9%      194  16.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      4   0.5%      4   0.3% 
Asian      47  11.7%      93  11.5%      140  11.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      20   5.0%      48   6.0%      68   5.6% 
White      276  68.8%      524  65.0%      800  66.3% 
More than one race      0   0.0%      1   0.1%      1   0.1% 
Unknown or Not Reported      58  14.5%      136  16.9%      194  16.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Australia   11   30   41 
Austria   2   4   6 
Belgium   3   4   7 
Canada   21   61   82 
Czech Republic   14   20   34 
Denmark   7   14   21 
Finland   5   7   12 
France   21   39   60 
Germany   20   31   51 
Hungary   1   4   5 
Israel   7   7   14 
Italy   12   24   36 
Japan   21   34   55 
Netherlands   11   8   19 
New Zealand   2   6   8 
Norway   3   4   7 
Poland   6   28   34 
Romania   5   7   12 
Russia   11   24   35 
Slovakia   6   11   17 
South Africa   17   35   52 
Spain   36   95   131 
Sweden   3   10   13 
Taiwan, Province Of China   5   14   19 
United Kingdom   38   61   99 
United States   113   224   337 


  Outcome Measures

1.  Primary:   Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)   [ Time Frame: Up to approximately 43 Months ]

2.  Secondary:   Time to Metastasis (TTM)   [ Time Frame: Up to approximately 43 Months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to approximately 43 Months ]

4.  Secondary:   Time to Symptomatic Progression   [ Time Frame: Up to approximately 43 Months ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to approximately 43 months ]

6.  Secondary:   Time to Initiation of Cytotoxic Chemotherapy   [ Time Frame: Up to approximately 43 months ]


  Serious Adverse Events


  Other Adverse Events


  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
These results are up to clinical cutoff (CCO) date (that is, 19 May 2017).


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Medical Director, WC Clinical Oncology Department
Organization: Janssen Research & Development, LLC
phone: 844-434-4210
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01946204     History of Changes
Other Study ID Numbers: CR102931
ARN-509-003 ( Other Identifier: Aragon Pharmaceuticals, Inc. )
2012-004322-24 ( EudraCT Number )
First Submitted: September 17, 2013
First Posted: September 19, 2013
Results First Submitted: May 18, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018