Phase II trial of abiraterone acetate in patients with relapsed and/or metastatic, castration resistant, salivary gland cancers.

Phase 1

• Conditions: relapsed and/or metastatic, castration resistant, salivary gland cancer; MedDRA version: 17.0Level: LLTClassification code 10026677Term: Malignant salivary gland cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001274-34-IT
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-08
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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 <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

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 <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.
- Subjects who have partners of childbearing potential who are not willing to 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
- 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 & T1] or any cancer curatively treated > 3 years prior to study entry

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate;Secondary Objective: - Disease Control Rate (DCR)<br>- Incidence of adverse events (AEs), according to the National Cancer <br>- Institute Common Toxicity Criteria (NCI-CTC) version 4.0<br>- Progression free survival<br>- Overall survival<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): • Disease Control Rate (DCR)<br>• Incidence of adverse events (AEs), according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0<br>• Progression free survival<br>• Overall survival<br>;Timepoint(s) of evaluation of this end point: 4 years