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

NCT02867852 | Completed Phase 2

• 1 other identifier: INT 71/14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or disseminated AR-expressing disease. No other therapy except palliative chemotherapy is available after progression on ADT, thus underling the necessity of alternative therapeutic approaches.

Conditions

Salivary Glands Tumors

Outcome Measures

Primary Outcomes (1)

• Response rate

  The assessment of the activity considered as the response rate of abiraterone acetate in castration resistant salivary glands cancer

  4 years

Secondary Outcomes (4)

• Disease Control Rate

  4 years

• Adverse Events incidence

  4 years

• Progression free survival

  4 years

• Overall survival

  4 years

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

Abiraterone acetate 1 g/day must be taken as four 250-mg tablets daily on an empty stomach. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least 1 hour after the dose of abiraterone acetate is taken. Prednisone (prednisolone when prednisone is not available) 5 mg will be given orally twice a day.

Drug: Abiraterone acetate

Interventions

Abiraterone acetate DRUG

Abiraterone acetate is a prodrug of abiraterone, an irreversible inhibitor of 17α hydroxylase/C17, 20-lyase (cytochrome P450c17 \[CYP17\]), a key enzyme required for testosterone synthesis. This enzyme is found in the testes, adrenals, prostate tumors

Also known as: Zytiga

Abiraterone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Related Publications (1)

• Locati LD, Cavalieri S, Bergamini C, Resteghini C, Colombo E, Calareso G, Mariani L, Quattrone P, Alfieri S, Bossi P, Platini F, Capone I, Licitra L. Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial. J Clin Oncol. 2021 Dec 20;39(36):4061-4068. doi: 10.1200/JCO.21.00468. Epub 2021 Oct 1.

  PMID: 34597119 DERIVED

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lisa Licitra, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: March 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)