Activity of Abiraterone Acetate in the management of Cushing’s syndrome in patients with adrenocortical carcinoma (ABACUS) - ABACUS

AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 30 人开始时间: 2020年11月4日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•Histologically-confirmed diagnosis of ACC
•CT or MRI evidence of metastatic or locally advanced ACC (ENSAT stage III-IV) unsuitable for radical surgery
•Age = 18 years
•Confirmed diagnosis of Cushing’s syndrome validated by:
•-two 24 h urinary collections for UFC at least 1.5 times the upper the normal levels, within 2 weeks prior to enrollment;
•-serum ACTH levels lower than the normal range;
•ECOG performance status = 2
•Effective contraception
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Life expectancy less than 3 months
•Liver disease, such as cirrhosis, chronic or persistent active hepatitis or AST/ALT > 2 x ULN, bilirubin >2 x ULN
•Heart failure (NYHA class III or IV), unstable angina, severe arrhythmia or clinically significant impairment of heart function
•Major surgical procedure within one month prior entering the study
•Renal impairment (creatinine clearance < 40 ml/min).
•WBC <3 x 109 /L; Hb <13 g/dL for men and <12 g/dL for women; platelets <100 x 109 /L
•Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
•Pregnant or breast-feeding women
•History of alcohol or drug abuse
•History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years)
•Acute or chronic uncontrolled infections
•Patient non-compliance

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