CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 31 enrolled / 31 target
Drug / intervention
Apalutamide +1 moredrug
Likely dose
Apalutamide 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04325828
NCT04325828Phase 2ActiveUpdate Overdue (0.4/mo)Completion was 60mo ago
CompareCT.gov

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

Janssen Pharmaceutical K.K.·interventional·Posted Mar 30, 2020·Updated Jun 5, 2026

In Brief

A Phase 2 clinical trial evaluating Apalutamide and GnRH Agonist for Salivary Gland Neoplasms. Active but no longer recruiting, targeting 31 participants across 7 sites.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSalivary Gland Neoplasms
CountriesJapan
Collaborators--

Timeline

Phase 2Active
20212022202320242025202620272028
First PostedMar 30, 2020
Enrollment StartApr 7, 2020
Primary CompletionJun 9, 2021
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.3 years ago

Arms & Interventions

Apalutamide plus GnRH Agonistexperimental

Participants will receive apalutamide 240 milligram (mg) in combination with a gonadotropin-releasing hormone (GnRH) agonist until disease progression, unacceptable toxicity, death, or the end of the study and each treatment cycle will be of 28 days. Participants who are benefitting from this study will enter long term extension phase.

Drug: ApalutamideDrug: GnRH Agonist

Interventions

Apalutamidedrug

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

GnRH Agonistdrug

A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist.