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 50 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) 30 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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | NLD | GBR | FRA | ESP | BEL 5
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 USA | CAN 0
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 19
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) Active, not recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 22


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