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

NCT04325828 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: CR10875856021927SGT2001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

Brief 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

Salivary Gland Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.

  Up to 13 months

Secondary Outcomes (9)

• Clinical Benefit Rate (CBR)

  Up to 13 months

• Disease Control Rate (DCR)

  Up to 13 months

• Progression-free Survival (PFS) as Assessed by ICRR

  Up to 13 months

• Overall Survival (OS)

  Up to 13 months

• Time to Response (TTR)

  Up to 13 months

Study Arms (1)

Apalutamide plus GnRH Agonist

EXPERIMENTAL

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: Apalutamide; Drug: GnRH Agonist

Interventions

GnRH Agonist DRUG

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

Apalutamide plus GnRH Agonist

Apalutamide DRUG

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

Also known as: JNJ-56021927

Apalutamide plus GnRH Agonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed salivary gland carcinoma (SGC) by local pathology
• Androgen receptor (AR) expressing SGC: Local testing of AR-positivity will be performed as standard of care for the eligibility confirmation. AR-positivity will be defined according to immunohistochemistry (IHC) staining of tumor tissue with at least 1 percent (%) of cell nuclei staining positive. Tissue should be available for the central confirmation of AR-positivity, but the central result of AR positivity will not be required for initiating the study intervention
• Locally advanced or recurrent/metastatic SGC
• Measurable lesion(s) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

You may not qualify if:

• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to first dose. Treatment with a drug that has a short half life (t1/2) (for example, less than \[\<\] 1 day) may be eligible in accordance with the discussion with the sponsor's medical monitor
• Radiographically confirmed brain metastases. In case of history of brain metastases that were previously treated and not recurred for at least 6 months, they are considered eligible
• Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less (except for all grade alopecia, and for peripheral neuropathy, and hypothyroidism stable on hormone replacement therapy to be Grade 2 or less). If corticosteroids are administered for any reasons such as the management of toxicities due to prior therapies, the dose must be tapered until 10 milligram (mg)/day or less of prednisolone and contact the sponsor's medical monitor on an individual basis prior to the first dose
• Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
• History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness less than or equal to \[\<=\] 1 year prior to first dose; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Treatment with drugs known to lower the seizure threshold within 4 weeks prior to first dose
• Known or suspected contraindications or hypersensitivity to apalutamide, gonadotropin-releasing hormone agonist (GnRHa) analogues or any of the components of the formulations
• Received prior ADT including a GnRH analogue, AR blocker such as bicalutamide, enzalutamide or 17alpha-hydroxylase-17,20-lyase (CYP17) inhibitor such as abiraterone acetate etc. Chemotherapy, radiation, or surgery as part of curative intent therapy are allowed so long as prior therapy did not include ADT. Prior chemotherapy, targeted cancer therapy or immunotherapy within 1 week or 4 half-lives whichever is longer, before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 2 weeks

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (7)

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan

Location

Kansai Medical University Hospital

Hirakata, 573 1191, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, 791 0280, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464 8681, Japan

Location

Niigata University Medical And Dental Hospital

Niigata, 951 8520, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

apalutamide; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Due to the low numbers of female participants, it was difficult to interpret the difference between males and females. There was a lack of data on individual treatment of apalutamide as well as goserelin. The number of participants in this study was limited, and the follow-up period was immature at this cut-off for the primary analysis.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: April 7, 2020
• Primary Completion: June 9, 2021
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026
• Results First Posted: July 6, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)