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| ID | Type | Description | Link |
|---|---|---|---|
| 67652000MPC4002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib plus Abiraterone Acetate (Nira/AA) combination | Drug | Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets. | ||
| Prednisone/Prednisolone | Drug | Prednisone/Prednisolone 10 mg will be administered orally. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
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