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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR APALUTAMIDE


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All Clinical Trials for Apalutamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01171898 ↗ Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) Active, not recruiting Aragon Pharmaceuticals, Inc. Phase 1/Phase 2 2010-07-26 The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.
NCT01946204 ↗ A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer Active, not recruiting Aragon Pharmaceuticals, Inc. Phase 3 2013-10-14 The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.
NCT02106507 ↗ ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate Completed Aragon Pharmaceuticals, Inc. Phase 1 2014-04-01 The purpose of this study is to test the safety of the combination of apalutamide plus everolimus at different dose levels.
NCT02106507 ↗ ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate Completed Memorial Sloan Kettering Cancer Center Phase 1 2014-04-01 The purpose of this study is to test the safety of the combination of apalutamide plus everolimus at different dose levels.
NCT02257736 ↗ An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRP Active, not recruiting Aragon Pharmaceuticals, Inc. Phase 3 2014-11-26 The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).
NCT02366494 ↗ Micro RNAs to Predict Response to Androgen Deprivation Therapy Active, not recruiting Medical College of Wisconsin 2015-04-29 Identify exosomal micro RNA that predict responses to ADT
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Apalutamide

Condition Name

Condition Name for Apalutamide
Intervention Trials
Prostate Cancer 34
Prostatic Neoplasms 13
Prostate Adenocarcinoma 12
Stage IVA Prostate Cancer AJCC v8 11
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Condition MeSH

Condition MeSH for Apalutamide
Intervention Trials
Prostatic Neoplasms 92
Adenocarcinoma 18
Carcinoma 9
Neoplasms 6
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Clinical Trial Locations for Apalutamide

Trials by Country

Trials by Country for Apalutamide
Location Trials
United States 487
Canada 51
Brazil 22
Japan 19
Australia 14
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Trials by US State

Trials by US State for Apalutamide
Location Trials
California 32
New York 28
Texas 27
Pennsylvania 21
South Carolina 17
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Clinical Trial Progress for Apalutamide

Clinical Trial Phase

Clinical Trial Phase for Apalutamide
Clinical Trial Phase Trials
Phase 4 2
Phase 3 16
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Apalutamide
Clinical Trial Phase Trials
Recruiting 41
Active, not recruiting 24
Not yet recruiting 13
[disabled in preview] 20
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Clinical Trial Sponsors for Apalutamide

Sponsor Name

Sponsor Name for Apalutamide
Sponsor Trials
National Cancer Institute (NCI) 18
Janssen Scientific Affairs, LLC 12
Janssen Research & Development, LLC 11
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Sponsor Type

Sponsor Type for Apalutamide
Sponsor Trials
Industry 81
Other 75
NIH 19
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