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Get Free AccessTPS176 Background: Clinical benefit has been observed with poly(ADP-ribose) polymerase (PARP) inhibition in patients with metastatic castration-resistant prostate cancer tumors that carry HRR gene defects. Niraparib is a highly selective and potent PARP inhibitor, with activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. The objective of AMPLITUDE is to assess the efficacy and safety of niraparib/placebo added to AAP with androgen deprivation therapy (ADT) in a biomarker-selected population with mCSPC. Methods: AMPLITUDE (NCT04497844) is a phase 3, randomized, double-blind, placebo-controlled study with an expected enrollment of 788 patients at ~350 sites in ~30 countries. Clinical trial information: NCT04497844. [Table: see text]
Dana E. Rathkopf, Kim N., David Olmos, Heather H. Cheng, Neeraj Agarwal, Julie N. Graff, Shahneen Sandhu, Vinny Hayreh, Angela Lopez‐Gitlitz, Peter Francis, Gerhardt Attard (2021). AMPLITUDE: A study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).. , 39(6_suppl), DOI: https://doi.org/10.1200/jco.2021.39.6_suppl.tps176.
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Type
Article
Year
2021
Authors
11
Datasets
0
Total Files
0
Language
en
DOI
https://doi.org/10.1200/jco.2021.39.6_suppl.tps176
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