New drug combo shows promise for rare salivary gland cancer
NCT ID NCT04325828
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tests whether a combination of two hormone-blocking drugs (apalutamide and a GnRH agonist) can shrink or slow the growth of advanced salivary gland cancer that has a specific protein called the androgen receptor. About 31 adults with locally advanced or spread cancer that has this receptor will receive the treatment. The main goal is to see how many patients have their tumors shrink or disappear.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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31 people
The number who actually took part.
- Started
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Apr 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Center Hospital
Nagoya, 464 8681, Japan
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Hokkaido University Hospital
Sapporo, 060-8648, Japan
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Kansai Medical University Hospital
Hirakata, 573 1191, Japan
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National Cancer Center Hospital
Chūōku, 104 0045, Japan
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National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
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National Hospital Organization Shikoku Cancer Center
Matsuyama, 791 0280, Japan
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Niigata University Medical And Dental Hospital
Niigata, 951 8520, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets Hard-to-Treat salivary gland tumors
- Can a new drug combo shrink Hard-to-Treat salivary gland tumors?
- New PET tracer could spot cancers that standard scans overlook
- Drug duo takes on rare head and neck tumors
- New pill-chemo combo takes on hard-to-treat cancers
- Common pain gel could shield cancer patients from radiation burns