relapsed and/or metastatic, castration resistant, salivary gland cancer MedDRA version: 17.0 Level: LLT Classification code 10026677 Term: Malignant salivary gland cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Zytiga
Product Name: Abiraterone Acetato
Pharmaceutical Form: Tablet
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - Histologically or cytologically confirmed salivary glands cancer. - At least, one target lesion defined as RECIST 1.1 (clear progression of disease is required in the presence of one target lesion previously treated with radiotherapy - Clinical and/or radiological progression of disease on ADT - No limits are required for the number of previous chemotherapy lines - Age =18 years - Eastern Cooperative Oncology Group (ECOG) performance status of =2 - Hemoglobin = 9.0 g/dL independent of transfusion - Platelet count = 100,000/µL - Serum albumin = 3.0 g/dL - Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Received abiraterone acetate within the last 5 years - Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection - Abnormal liver functions consisting of any of the following: Serum bilirubin = 1.5 x ULN (except for subjects with documented Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 x ULN Patients with ALT and/or AST not exceeding 5X ULN due to liver mets can be enrolled - Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. - Active or symptomatic viral hepatitis or chronic liver disease - History of pituitary or adrenal dysfunction - Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of 3 years prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate;Secondary Objective: - Disease Control Rate (DCR) - Incidence of adverse events (AEs), according to the National Cancer - Institute Common Toxicity Criteria (NCI-CTC) version 4.0 - Progression free survival - Overall survival ;Primary end point(s): To assess the activity of abiraterone acetate plus prednisone in castration resistant SGCs;Timepoint(s) of evaluation of this end point: 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Disease Control Rate (DCR) • Incidence of adverse events (AEs), according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0 • Progression free survival • Overall survival ;Timepoint(s) of evaluation of this end point: 4 years | — |
Countries
Italy
Contacts
Public ContactUfficio Trial Center
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed