Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
NCT ID: NCT05694819
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2020-04-17
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Darolutamide monotherapy
Targeted patients: 24
Darolutamide
Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.
Darolutamide plus Goserelin
Targeted patients: 32
Darolutamide
Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.
Goserelin
Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.
Interventions
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Darolutamide
Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.
Goserelin
Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
4. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
5. Presence of measurable or evaluable disease according to RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Adequate organ or bone marrow function
8. Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.
Darolutamide and Goserelin combination therapy group:
1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
4. Histologically confirmed as salivary gland carcinoma at the medical institution.
5. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
6. Presence of measurable or evaluable disease according to RECIST v1.1
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
8. Adequate organ or bone marrow function
9. Patients who agree to practice effective barrier contraception refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of the study drug.
Exclusion Criteria
1. Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
2. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
3. Metastases in the brain/central nervous system (CNS).
4. Patients who are pregnant or breastfeeding.
5. Synchronous or metachronous malignancies.
6. Participant has a known history of HIV infection.
7. A positive test result for any of the followings:
* HBsAg positive
* HBsAb positive and hepatitis B virus (HBV)-DNA positive
* HBcAb positive and HBV-DNA positive
8. Severe or uncontrolled concurrent heart disease or hypertension.
9. Inability to swallow oral medications.
Darolutamide and Goserelin combination therapy group:
1. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin
2. Prior treatment with Darolutamide or Goserelin.
3. Metastases in the brain/CNS.
4. Patients who are pregnant or breastfeeding.
5. Synchronous or metachronous malignancies.
6. Participant has a known history of HIV infection.
7. A positive test result for any of the followings:
* HBsAg positive
* HBsAb positive and HBV-DNA positive
* HBcAb positive and HBV-DNA positive
8. Severe or uncontrolled concurrent heart disease or hypertension.
9. Inability to administer Darolutamide or Goserelin.
20 Years
ALL
No
Sponsors
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Bayer Yakuhin, Ltd.
INDUSTRY
National Cancer Center Hospital East
OTHER
Responsible Party
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Makoto Tahara
Chief, Department of Head and Neck Medical Oncology
Principal Investigators
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Makoto Tahara, MD, PhD
Role: STUDY_DIRECTOR
National Cancer Center Hospital East
Naomi Kiyota, MD, PhD
Role: STUDY_CHAIR
Kobe University Hospital
Susumu Okano, MD, PhD
Role: STUDY_CHAIR
National Cancer Center Hospital East
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Chiba University Hospital
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
The Jikei University Hospital
Tokyo, Tokyo, Japan
Tokyo Medical And Dental University Hospital
Tokyo, Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Tokyo, Japan
Countries
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Other Identifiers
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jRCT2031190241
Identifier Type: REGISTRY
Identifier Source: secondary_id
YCU19003
Identifier Type: -
Identifier Source: org_study_id
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