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 | |
| NCT02489318 ↗ | A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC | Active, not recruiting | Aragon Pharmaceuticals, Inc. | Phase 3 | 2015-11-27 | The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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