A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer

Medivation, Inc.0 个研究点目标入组 118 人开始时间: 2013年5月16日最近更新: 2020年2月1日

适应症

试验速览

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•Advanced AR+ (any nuclear AR staining by IHC) TNBC, where advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent;
•Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer;
•Either measurable disease or bone-only nonmeasurable disease;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•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 95
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Current or previously treated brain metastasis or active leptomeningeal disease; head imaging is required during screening;
•Current hormone replacement therapy;
•Abnormal hematology, liver function tests and creatinine laboratory values at screening;
•History of seizure or any condition that may predispose to seizure;
•History of loss of consciousness or transient ischemic attack within past 12 months;
•An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease; uncontrolled celiac disease);
•Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700); patients who received treatment for < 28 days or placebo on an investigational study are acceptable;
•Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene

发起方