Abiraterone Acetate in Patients With Relapsed and/or Metastatic Salivary Gland Cancers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02867852
• Date of registration: 11/08/2016
• Prospective Registration: No
• Primary sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Public title: Abiraterone Acetate in Patients With Relapsed and/or Metastatic Salivary Gland Cancers SG-ABI14
• Scientific title: Phase II Trial of Abiraterone Acetate in Patients With Relapsed and/or Metastatic, Castration Resistant Salivary Gland Cancers
• Date of first enrolment: March 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02867852
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Lisa Licitra, MD
• Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent

- Age =18 years

- 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

- Ongoing androgen deprivation with a serum testosterone level of less than 50 ng per
deciliter (1.7 nmol per liter)

- Eastern Cooperative Oncology Group (ECOG) performance status of =2

- Adequate bone marrow function: Neutrophils > 1.5 x 109/L; Hemoglobin = 9.0 g/dL
independent of transfusion and platelet count = 100,000/µL

- No limits are required for the number of previous chemotherapy lines

- Serum albumin = 3.0 g/dL

- Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine
clearance = 60 mL/min

- Serum potassium =3.5 mmol/L

- Able to swallow the study drug whole as a tablet

- Patients with treated brain metastases, stable within the last three months, are
allowed

- Subjects who have partners of childbearing potential must use a method of birth
control with adequate barrier protection as determined to be acceptable by the
investigator and for 13 weeks after last study drug administration

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 5 x 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 <50% at baseline

- History of gastrointestinal disorders (medical disorders or extensive surgery) that
may interfere with the absorption of the study drug

- Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved
to a NCI-CTCAE (Version 4.0) Grade of =1

- Participation in clinical trials with other experimental agents within 30 days of
study entry or concomitant treatment with other experimental drug

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study except cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively
treated > 3 years prior to study entry



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Salivary Glands Tumors

Intervention(s)

Drug: Abiraterone acetate

Primary Outcome(s)

Response rate [Time Frame: 4 years]

Secondary Outcome(s)

Progression free survival [Time Frame: 4 years]

Overall survival [Time Frame: 4 years]

Adverse Events incidence [Time Frame: 4 years]

Disease Control Rate [Time Frame: 4 years]

Secondary ID(s)

INT 71/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors