Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Carcinoma

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Kennedy Disease

Oral Cancer

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Hormones

Goserelin

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.

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

Apalutamide

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

GnRH Agonist

Janssen Pharmaceutical K.K., Japan Clinical Trial

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).

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

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

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.

Clinical benefit rate (CBR) was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% 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. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

DCR was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% 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. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

PFS was defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Overall survival (OS) was defined as the time from the date of the initial dose of study intervention to the date of the participant's death.

TTR was defined among responders (with a CR or PR) as the time between date of the initial dose of study intervention and the first efficacy evaluation that the participant had met all criteria for CR or PR. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% 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.

DoR calculated among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30 % 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.

Number of participants with TEAEs were reported. Treatment-emergent adverse events (TEAEs) for the treatment phase included events with an onset date/time on or after the start of study intervention through the day of last dose plus 30 days were considered as treatment-emergent.

Plasma concentration of apalutamide was reported.

Plasma concentration of N-desmethyl Apalutamide was reported.

Janssen Pharmaceutical K.K.

Safety analysis set included all participants who received at least 1 dose of study intervention.

Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.

Apalutamide + Goserelin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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.

Executive Medical Director

Response evaluable set included all participants who were androgen receptor (AR) positive by local test and were confirmed evaluable by independent central radiology review (ICRR) and also, who received at least 1 dose of study drug and had at least 1 postbaseline disease assessment or died due to disease progression before first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.

Overall Response Rate (ORR)

Response evaluable set included all participants who were AR positive by local test and who were confirmed evaluable by an ICRR and also, all participants who received at least 1 dose of study intervention and who had at least 1 postbaseline disease assessment or died due to disease progression before the first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

Treated analysis set included all participants who received at least 1 dose of study intervention.

Progression-free Survival (PFS) as Assessed by ICRR

Overall Survival (OS)

Population analyzed included response evaluable set amongst who were responders (CR or PR).

Time to Response (TTR)

Duration of Response (DoR)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Cycle 02 Day 1, Predose

Cycle 03 Day 1, Predose

Cycle 04 Day 1, Predose

Cycle 05 Day 1, Predose

Cycle 06 Day 1, Predose

Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.

Plasma Concentration of Apalutamide

Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.

Spots Global Cancer Trial Database for A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma

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