ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): Phase 3 Multicenter, Randomized Study of Rucaparib versus Chemotherapy in Patients with Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - ARIEL4

Clovis Oncology, Inc.0 个研究点目标入组 345 人开始时间: 2016年11月21日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1.Be 18 years of age at the time the informed consent form is signed.
•2.Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometroid epithelial ovarian, fallopian tube, or primary peritoneal cancer.
•3.Received = 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment.
•4.Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation.
•5.Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses.
•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 310
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•1.History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first dose of rucaparib).
•2.Prior treatment with any PARP inhibitor.
•3.Symptomatic and/or untreated central nervous system metastases.
•4.Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib.
•5.Women who are pregnant or breast feeding.
•6.Hospitalization for bowel obstruction within 3 months prior to enrollment.

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