Trial · NCT04325828
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
NCT04325828, Phase 2, Active not recruiting, Janssen Pharmaceutical K.K.; results first posted 2022-07-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma. Trials, record NCT04325828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04325828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
- NCT number
- NCT04325828
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Salivary Gland Neoplasms
- Interventions
- Apalutamide, GnRH Agonist
- First posted
- 2020-03-30
- Last updated
- 2026-11-04
- Results first posted
- 2022-07-06
- 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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 13 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 13 months | 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. |
| Secondary | Disease Control Rate (DCR) | Up to 13 months | 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. |
| Secondary | Progression-free Survival (PFS) as Assessed by ICRR | Up to 13 months | 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. |
| Secondary | Overall Survival (OS) | Up to 13 months | 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. |
| Secondary | Time to Response (TTR) | Up to 13 months | 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. |
| Secondary | Duration of Response (DoR) | Up to 13 months | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 13 months | 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. |
| Secondary | Plasma Concentration of Apalutamide | Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days) | Plasma concentration of apalutamide was reported. |
| Secondary | Plasma Concentration of N-desmethyl Apalutamide | Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days) | Plasma concentration of N-desmethyl Apalutamide was reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 13 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Up to 13 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Up to 13 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) as Assessed by ICRR | Up to 13 months | Treated analysis set included all participants who received at least 1 dose of study intervention. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 13 months | Treated analysis set included all participants who received at least 1 dose of study intervention. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | Up to 13 months | Population analyzed included response evaluable set amongst who were responders (CR or PR). | months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | Up to 13 months | Population analyzed included response evaluable set amongst who were responders (CR or PR). | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 13 months | Safety analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of Apalutamide | Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days) | 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. | micrograms per milliliter (mcg/mL) | MEAN |
| SECONDARY | Plasma Concentration of N-desmethyl Apalutamide | Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days) | 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. | mcg/mL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Apalutamide + Goserelin | 25 | percentage of participants | ||
| Clinical Benefit Rate (CBR) | Apalutamide + Goserelin | 50 | percentage of participants | ||
| Disease Control Rate (DCR) | Apalutamide + Goserelin | 70.8 | percentage of participants | ||
| Progression-free Survival (PFS) as Assessed by ICRR | Apalutamide + Goserelin | 7.43 | 95% Confidence Interval 3.65 to NA | months | |
| Overall Survival (OS) | Apalutamide + Goserelin | NA | 95% Confidence Interval NA to NA | months | |
| Time to Response (TTR) | Apalutamide + Goserelin | 1.87 | Full Range 1.7 to 3.7 | months | |
| Duration of Response (DoR) | Apalutamide + Goserelin | NA | 95% Confidence Interval 6.64 to NA | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Apalutamide + Goserelin | 28 | Participants | ||
| Plasma Concentration of Apalutamide | Apalutamide + Goserelin | Cycle 02 Day 1, Predose | 4.67 | Standard Deviation 1.19 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Apalutamide | Apalutamide + Goserelin | Cycle 03 Day 1, Predose | 4.32 | Standard Deviation 1.35 | micrograms per milliliter (mcg/mL) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apalutamide + Goserelin | 31 | |
| Overall Study | COMPLETED | Apalutamide + Goserelin | 5 | |
| Overall Study | NOT COMPLETED | Apalutamide + Goserelin | 26 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Apalutamide + Goserelin | 4 | 31 | |
| other | Leukopenia | Blood and lymphatic system disorders | Apalutamide + Goserelin | 3 | 31 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Apalutamide + Goserelin | 2 | 31 | |
| other | Hypothyroidism | Endocrine disorders | Apalutamide + Goserelin | 6 | 31 | |
| other | Constipation | Gastrointestinal disorders | Apalutamide + Goserelin | 3 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Apalutamide + Goserelin | 2 | 31 | |
| other | Nausea | Gastrointestinal disorders | Apalutamide + Goserelin | 4 | 31 | |
| other | Stomatitis | Gastrointestinal disorders | Apalutamide + Goserelin | 2 | 31 | |
| other | Malaise | General disorders | Apalutamide + Goserelin | 5 | 31 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Apalutamide + Goserelin | 2 | 31 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apalutamide + Goserelin | 4 | 31 |
| Total, other adverse events | Apalutamide + Goserelin | 28 | 31 |
| Total, serious adverse events | Apalutamide + Goserelin | 5 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04325828
GET https://conductscience.org/api/trials/v1/NCT04325828/events?page=2