Trials / Active Not Recruiting
Active Not RecruitingNCT04325828
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Janssen Pharmaceutical K.K. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-04-07
- Primary completion
- 2021-06-09
- Completion
- 2027-12-31
- First posted
- 2020-03-30
- Last updated
- 2026-04-13
- Results posted
- 2022-07-06
Locations
7 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04325828. Inclusion in this directory is not an endorsement.