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Trial · Interventional

Active, not recruitingPhase 2Results postedRegistry data

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

Short name YATAGARASU

NCTNCT04325828 (opens ClinicalTrials.gov in a new tab)Other idCR108758Other id56021927SGT2001
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the description.

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
31 participants (actual)
Sponsor
Janssen Pharmaceutical K.K. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Japan

Start
7 Apr 2020
Primary completion
9 Jun 2021
Completion
31 Dec 2027 (estimated)
First posted
30 Mar 2020
Last update posted
25 Sept 2026
Conditions
Salivary Gland Neoplasms

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202022202420262028
  1. Ph 2

    YATAGARASU

    NCT04325828

    7 Apr 2020 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • ApalutamideDrug
  • GnRH AgonistDrug

Arms1

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Overall Response Rate (ORR)

    Time frame · Up to 13 months

    Registry description

    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 outcomes(9)

  1. Clinical Benefit Rate (CBR)

    Time frame · Up to 13 months

    Registry description

    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.

  2. Disease Control Rate (DCR)

    Time frame · Up to 13 months

    Registry description

    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.

  3. Progression-free Survival (PFS) as Assessed by ICRR

    Time frame · Up to 13 months

    Registry description

    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.

  4. Overall Survival (OS)

    Time frame · Up to 13 months

    Registry description

    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.

  5. Time to Response (TTR)

    Time frame · Up to 13 months

    Registry description

    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.

  6. Duration of Response (DoR)

    Time frame · Up to 13 months

    Registry description

    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.

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

    Time frame · Up to 13 months

    Registry description

    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.

  8. Plasma Concentration of Apalutamide

    Time frame · Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)

    Registry description

    Plasma concentration of apalutamide was reported.

  9. Plasma Concentration of N-desmethyl Apalutamide

    Time frame · Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)

    Registry description

    Plasma concentration of N-desmethyl Apalutamide was reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to 13 months

Overall Response Rate (ORR)

GroupValue (percentage of participants)
Apalutamide + Goserelin25
Secondary and other outcome results(7)
Secondary outcomeNumber· Up to 13 months

Clinical Benefit Rate (CBR)

GroupValue (percentage of participants)
Apalutamide + Goserelin50
Secondary outcomeNumber· Up to 13 months

Disease Control Rate (DCR)

GroupValue (percentage of participants)
Apalutamide + Goserelin70.8
Secondary outcomeMedian· Up to 13 months

Progression-free Survival (PFS) as Assessed by ICRR

GroupValue (months)
Apalutamide + Goserelin7.43
Secondary outcomeMedian· Up to 13 months

Overall Survival (OS)

GroupValue (months)
Apalutamide + GoserelinNA
Secondary outcomeMedian· Up to 13 months

Time to Response (TTR)

GroupValue (months)
Apalutamide + Goserelin1.87
Secondary outcomeMedian· Up to 13 months

Duration of Response (DoR)

GroupValue (months)
Apalutamide + GoserelinNA
Secondary outcomeCount of participants· Up to 13 months

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

GroupValue (Participants)
Apalutamide + Goserelin28

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Apalutamide + GoserelinParticipants 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.4 / 315 / 3128 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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