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

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04325828
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Salivary Gland Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Apalutamide 240 mg (4\*60-mg tablets) will be administered orally once daily with or without food.
  • GnRH Agonist — DRUG
    A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist.

Study Details

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).

Key Dates

Start date
Apr 7, 2020
Status verified
Jun 2026
Primary completion
Jun 9, 2021
Completion
Dec 31, 2027

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide plus GnRH Agonist
    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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 13 months ]

Related Studies