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ATTIVO

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. The objective of this study is to compare niraparib and abiraterone acetate plus prednisone (AA-P) versus placebo plus AA-P plus for the treatment of subjects with various stages of metastatic prostate cancer. This protocol will describe the overall conduct of the study and is intended to act as a master protocol for the niraparib and AA-P combination. The study will begin with niraparib in combination with AA-P for subjects with first-line (L1) metastatic castration-resistant prostate cancer (mCRPC; defined as subjects who have not been treated with any therapy in the metastatic castrate- resistant setting, except for androgen deprivation therapy [ADT] and a limited exposure to AA-P). The sponsor may amend this protocol in the future to investigate the niraparib plus AA-P combination in additional stages of metastatic prostate cancer. These additional populations would be included as separate cohorts and would be analyzed independently.

 

STRUTTURA DI RIFERIMENTO

Ospedale S.Maria della Misericordia - Centro Operativo Studi Clinici S.C.Oncologia Medica

 

SCARICA DOCUMENTO DI SINOSSI

PER INFORMAZIONI CONTATTARE IL + 39 0755784107 O SCRIVERE  reteoncol.umbria@ospedale.perugia.it