Abiraterone Acetate in Patients With Relapsed and/or Metastatic Salivary Gland Cancers (SG-ABI14)
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|ClinicalTrials.gov Identifier: NCT02867852|
Recruitment Status : Unknown
Verified August 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was: Recruiting
First Posted : August 16, 2016
Last Update Posted : August 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Salivary Glands Tumors||Drug: Abiraterone acetate||Phase 2|
Carcinomas of the salivary glands (SGC) are rare tumors. They comprise less than 1% of all cancers of the head and neck. The standard treatment is surgical excision, followed by radiotherapy in selected cases, such as high-grade tumors, and/or in the presence of perineural invasion, and/or in the presence of advanced disease. 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.
The proven activity of ADT in AR expressing SGC as well as in Pca, suggests a common clinical behaviour by apparently sharing the same biological background. Once Pca becomes resistant to castration it still remains driven by ligand-dependent AR signaling and further hormonal manipulations are active and efficacious. Abiraterone acetate is currently approved by FDA for castration-resistant prostate cancer (CRPC). We treated with abiraterone two patients with AR-positive adenocarcinoma who had progressed on ADT, both patients showed a partial response suggesting the activity of a second line hormonal therapy in SGCs.
Based on the above biological and clinical evidences, the aim of the trial is to assess the activity of abiraterone in AR-expressing castration resistant SGCs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Abiraterone Acetate in Patients With Relapsed and/or Metastatic, Castration Resistant Salivary Gland Cancers|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Abiraterone acetate
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
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
Other Name: Zytiga
- Response rate [ Time Frame: 4 years ]The assessment of the activity considered as the response rate of abiraterone acetate in castration resistant salivary glands cancer
- Disease Control Rate [ Time Frame: 4 years ]The assessment of disease control rate of abiraterone acetate in castration resistant salivary glands cancer
- Adverse Events incidence [ Time Frame: 4 years ]Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
- Progression free survival [ Time Frame: 4 years ]The assessment of progression free survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate
- Overall survival [ Time Frame: 4 years ]The assessment of overall survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867852
|Contact: Laura Licati, MD||+39 022390 ext firstname.lastname@example.org|
|Contact: Roberta Granata, MD||+39 022390 ext email@example.com|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|Milan, Lombardy, Italy, 20133|
|Contact: Laura Locati, MD +39 022390 ext 2805 firstname.lastname@example.org|
|Contact: Roberta Granata, MD +39 022390 ext 2765 email@example.com|
|Principal Investigator:||Lisa Licitra, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|