Clinical Trials /

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

NCT04325828

Description:

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).

Related Conditions:
  • Salivary Gland Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Apalutamide Combined With Androgen Deprivation Therapy in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CR108758
  • SECONDARY ID: 56021927SGT2001
  • NCT ID: NCT04325828

Conditions

  • Salivary Gland Neoplasms

Interventions

DrugSynonymsArms
ApalutamideJNJ-56021927Apalutamide plus GnRH Agonist
GnRH AgonistApalutamide plus GnRH Agonist

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Apalutamide plus GnRH AgonistExperimentalParticipants 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.
  • Apalutamide
  • GnRH Agonist

Eligibility Criteria

        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 fulfilling at least 1 of the following
             conditions: (a) Primary lesion of T4b; (b) Cervical lymph node metastasis of N2c, N3a
             or N3b; (c) Unresectable lesion equivalent to the condition of 'a' or 'b' above in
             case of recurrence; (d) Distant metastasis

          -  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 alopecia, peripheral neuropathy, and hypothyroidism
             stable on hormone replacement therapy to be Grade 2 or less)

          -  Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding
             disorders secondary to hepatic dysfunction

          -  Known or suspected contraindications or hypersensitivity to apalutamide,
             gonadotropin-releasing hormone agonist (GnRHa) analogues or any of the components of
             the formulations
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 42 months
Safety Issue:
Description:ORR is defined as the percentage of participants who achieve a confirmed best overall response of Complete Response (CR) or Partial Response (PR) evaluated by an independent central radiology review based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures

Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to 42 months
Safety Issue:
Description:CBR is defined as the percentage of participants who achieve a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1.
Measure:Disease Control Rate (DCR)
Time Frame:Up to 42 months
Safety Issue:
Description:DCR is defined as the percentage of participants who achieve a confirmed best overall response of CR, PR, or SD based on RECIST version 1.1.
Measure:Progression-free Survival (PFS)
Time Frame:Up to 42 months
Safety Issue:
Description:PFS is 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 occurs first.
Measure:Overall Survival (OS)
Time Frame:Up to 42 months
Safety Issue:
Description:OS is defined as the time from the date of the initial dose of study intervention to the date of the participant's death.
Measure:Time to Response (TTR)
Time Frame:Up to 42 months
Safety Issue:
Description:TTR is 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 has met all criteria for CR or PR.
Measure:Duration of Response (DOR)
Time Frame:Up to 42 months
Safety Issue:
Description:DOR will be 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.
Measure:Number of Participants with Adverse Events (AEs)
Time Frame:Up to 42 months
Safety Issue:
Description:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measure:Plasma Concentrations of Apalutamide and its Active Metabolite
Time Frame:Cycle 1 (postdose) and Cycle 2 to 6 (predose) (each cycle of 28 days)
Safety Issue:
Description:Plasma samples will be analyzed to determine concentrations of apalutamide and its active metabolite (N-desmethyl apalutamide).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Pharmaceutical K.K.

Last Updated

March 26, 2020