A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations - PROfound

AstraZeneca0 个研究点目标入组 340 人开始时间: 2017年1月3日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.Histologically confirmed diagnosis of prostate cancer.
•2.Candidate for treatment with enzalutamide or abiraterone with documented evidence of mCRPC.
•3.Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
•4.Ongoing therapy with LHRH analog or bilateral orchiectomy.
•5.Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
•6.Qualifying HRR mutation in tumor tissue by the Lynparza HRR Assay
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 102
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 238

•1.Any previous treatment with PARP inhibitor, including olaparib
•2.Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy.
•3.Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for =5 years.
•4.Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
•5.*Subjects with known brain metastases.

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