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

Phase 1

• Conditions: Cushing’s syndrome in patients with adrenocortical carcinoma; MedDRA version: 20.0Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000945-29-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified