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 : April 25, 2024
|
Sponsor:
Aragon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Prostatic Neoplasms |
Interventions |
Drug: Apalutamide Drug: Placebo |
Enrollment | 1207 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | Apalutamide |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
Started | 401 | 806 |
Treated | 398 | 803 |
Completed | 0 | 0 |
Not Completed | 401 | 806 |
Reason Not Completed | ||
Death | 38 | 59 |
Withdrawal by Subject | 37 | 50 |
Lost to Follow-up | 3 | 7 |
Ongoing | 316 | 687 |
Other | 7 | 3 |
Baseline Characteristics
Arm/Group Title | Placebo | Apalutamide | Total | |
---|---|---|---|---|
Arm/Group Description | 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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 401 | 806 | 1207 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 401 participants | 806 participants | 1207 participants | |
74.1 (7.92) | 73.7 (8.07) | 73.9 (8.02) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 401 participants | 806 participants | 1207 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
401 100.0%
|
806 100.0%
|
1207 100.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 401 participants | 806 participants | 1207 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)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 401 participants | 806 participants | 1207 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
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 401 participants | 806 participants | 1207 participants |
Australia |
11 2.7%
|
30 3.7%
|
41 3.4%
|
|
Austria |
2 0.5%
|
4 0.5%
|
6 0.5%
|
|
Belgium |
3 0.7%
|
4 0.5%
|
7 0.6%
|
|
Canada |
21 5.2%
|
61 7.6%
|
82 6.8%
|
|
Czech Republic |
14 3.5%
|
20 2.5%
|
34 2.8%
|
|
Denmark |
7 1.7%
|
14 1.7%
|
21 1.7%
|
|
Finland |
5 1.2%
|
7 0.9%
|
12 1.0%
|
|
France |
21 5.2%
|
39 4.8%
|
60 5.0%
|
|
Germany |
20 5.0%
|
31 3.8%
|
51 4.2%
|
|
Hungary |
1 0.2%
|
4 0.5%
|
5 0.4%
|
|
Israel |
7 1.7%
|
7 0.9%
|
14 1.2%
|
|
Italy |
12 3.0%
|
24 3.0%
|
36 3.0%
|
|
Japan |
21 5.2%
|
34 4.2%
|
55 4.6%
|
|
Netherlands |
11 2.7%
|
8 1.0%
|
19 1.6%
|
|
New Zealand |
2 0.5%
|
6 0.7%
|
8 0.7%
|
|
Norway |
3 0.7%
|
4 0.5%
|
7 0.6%
|
|
Poland |
6 1.5%
|
28 3.5%
|
34 2.8%
|
|
Romania |
5 1.2%
|
7 0.9%
|
12 1.0%
|
|
Russia |
11 2.7%
|
24 3.0%
|
35 2.9%
|
|
Slovakia |
6 1.5%
|
11 1.4%
|
17 1.4%
|
|
South Africa |
17 4.2%
|
35 4.3%
|
52 4.3%
|
|
Spain |
36 9.0%
|
95 11.8%
|
131 10.9%
|
|
Sweden |
3 0.7%
|
10 1.2%
|
13 1.1%
|
|
Taiwan, Province Of China |
5 1.2%
|
14 1.7%
|
19 1.6%
|
|
United Kingdom |
38 9.5%
|
61 7.6%
|
99 8.2%
|
|
United States |
113 28.2%
|
224 27.8%
|
337 27.9%
|
Outcome Measures
Adverse Events
Limitations and Caveats
These results are up to clinical cutoff (CCO) date (that is, 19 May 2017).
More Information
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: | Senior Medical Director, WC Clinical Oncology Department |
Organization: | Janssen Research & Development, LLC |
Phone: | 844-434-4210 |
EMail: | 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 |
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: | April 25, 2024 |