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).
Title
- Brief Title: A Study of Apalutamide Combined With GnRH Agonist 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
Interventions
Drug | Synonyms | Arms |
---|
Apalutamide | JNJ-56021927 | Apalutamide plus GnRH Agonist |
GnRH Agonist | | Apalutamide 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
Name | Type | Description | Interventions |
---|
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. | |
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
- 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
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 2 years and 9 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 2 years and 9 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 2 years and 9 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 2 years and 9 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 2 years and 9 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 2 years and 9 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 2 years and 9 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 2 years and 9 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: | Active, not recruiting |
Lead Sponsor: | Janssen Pharmaceutical K.K. |
Last Updated
August 25, 2021