drugset / Trial / NCT01969578

Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

NCT01969578

RandomizedParallel-groupOpen-labelTreatment

Summary

Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

Timeline

Start
2015-09-24
Primary completion
2023-08-23
Completion
2024-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicalutamide Other / unclassified 50 mg
Comparator Carboplatin Small molecule
Comparator Cisplatin Other / unclassified
Comparator Doxorubicin Other / unclassified
Comparator Paclitaxel Small molecule
Subject Triptorelin Other / unclassified

Indications