Therapy Detail
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| Therapy Name | Abiraterone + Niraparib + Prednisone |
| Synonyms | |
| Therapy Description |
Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abiraterone | Zytiga | CB7630 | Hormone - Anti-androgens 40 | Zytiga (abiraterone) inhibits cytochrome P-450c17, resulting in decreased androgen synthesis (PMID: 25560485). Zytiga (abiraterone) is FDA approved for patients with metastatic castration-resistant prostate cancer (FDA.gov). |
| Niraparib | Zejula | MK4827 | PARP Inhibitor (Pan) 27 | Zejula (niraparib) binds to and inhibits PARP, which may result in the accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved for use as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy, and as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious or suspected deleterious germline BRCA mutations and in complete or partial response to platinum-based chemotherapy (FDA.gov). |
| Prednisone | Adasone | Dehydrocortisone | Adasone (prednisone) is a corticosteroid which functions as an immunosuppressant and anti-inflammatory agent and which may stimulate apoptosis in tumor cells (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ATM inact mut | prostate cancer | predicted - sensitive | Abiraterone + Niraparib + Prednisone | Phase III | Actionable | In a Phase III trial (MAGNITUDE), Zejula (niraparib) in combination with Zytiga (abiraterone) and Adasone (prednisone) (AAP) significantly improved radiographic progression-free survival (16.5 vs 13.7 mo, HR 0.73, p=0.0217) compared to placebo and AAP in patients with metastatic castration-resistant prostate cancer harboring alterations in homologous recombination repair genes including ATM, BRCA1/2, BRIP1, CHEK2, FANCA, HDAC2, and PALB2 (J Clin Oncol 40, 2022 (suppl 6; abstr 12); NCT03748641). | detail... |
| CDK12 inact mut | prostate cancer | predicted - sensitive | Abiraterone + Niraparib + Prednisone | Phase III | Actionable | In a Phase III trial (MAGNITUDE), Zejula (niraparib) in combination with Zytiga (abiraterone) and Adasone (prednisone) (AAP) significantly improved radiographic progression-free survival (16.5 vs 13.7 mo, HR 0.73, p=0.0217) compared to placebo and AAP in patients with metastatic castration-resistant prostate cancer harboring alterations in homologous recombination repair genes including ATM, BRCA1/2, BRIP1, CHEK2, FANCA, HDAC2, and PALB2 (J Clin Oncol 40, 2022 (suppl 6; abstr 12); NCT03748641). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03748641 | Phase III | Abiraterone + Niraparib + Prednisone Abiraterone + Prednisone | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 22 |
| NCT04577833 | Phase I | Abiraterone + Niraparib + Prednisone | A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer | Active, not recruiting | USA | FRA | ESP | BEL | 7 |
| NCT04812366 | Phase II | Abiraterone + Apalutamide + Prednisone Apalutamide Abiraterone + Prednisone Apalutamide + Atezolizumab Abiraterone + Docetaxel + Prednisone Abiraterone + Niraparib + Prednisone | Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer (GUNS) | Recruiting | CAN | 0 |
| NCT04497844 | Phase III | Abiraterone + Niraparib + Prednisone Abiraterone + Prednisone | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 26 |
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