Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04325828
PHASE2

A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma

Sponsor: Janssen Pharmaceutical K.K.

View on ClinicalTrials.gov

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

Interventions

DRUG

Apalutamide

Apalutamide 240 mg (4\*60-mg tablets) will be administered orally once daily with or without food.

DRUG

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