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A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
Sponsor: Janssen Pharmaceutical K.K.
Summary
The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC).
Official title: An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2020-04-07
Completion Date
2027-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Apalutamide 240 mg (4\*60-mg tablets) will be administered orally once daily with or without food.
GnRH Agonist
A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist.
Locations (7)
National Cancer Center Hospital
Chūōku, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Kansai Medical University Hospital
Hirakata, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Niigata University Medical And Dental Hospital
Niigata, Japan
Hokkaido University Hospital
Sapporo, Japan