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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031190241 | Registry Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Bayer Yakuhin, Ltd. | INDUSTRY |
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This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darolutamide monotherapy | Experimental | Targeted patients: 24 |
|
| Darolutamide plus Goserelin | Experimental | Targeted patients: 32 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darolutamide | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators | The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators | Up to 13 month |
| Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee | The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee | Up to 13 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR will be defined 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. | Up to 13 month |
| Best Overall Response (BOR) |
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Inclusion Criteria:
Darolutamide monotherapy group:
Darolutamide and Goserelin combination therapy group:
Exclusion Criteria:
Darolutamide monotherapy group:
Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
Metastases in the brain/central nervous system (CNS).
Patients who are pregnant or breastfeeding.
Synchronous or metachronous malignancies.
Participant has a known history of HIV infection.
A positive test result for any of the followings:
Severe or uncontrolled concurrent heart disease or hypertension.
Inability to swallow oral medications.
Darolutamide and Goserelin combination therapy group:
Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin
Prior treatment with Darolutamide or Goserelin.
Metastases in the brain/CNS.
Patients who are pregnant or breastfeeding.
Synchronous or metachronous malignancies.
Participant has a known history of HIV infection.
A positive test result for any of the followings:
Severe or uncontrolled concurrent heart disease or hypertension.
Inability to administer Darolutamide or Goserelin.
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| Name | Affiliation | Role |
|---|---|---|
| Makoto Tahara, MD, PhD | National Cancer Center Hospital East | Study Director |
| Naomi Kiyota, MD, PhD | Kobe University Hospital | Study Chair |
| Susumu Okano, MD, PhD | National Cancer Center Hospital East | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Chiba University Hospital |
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| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D055534 | Bulbo-Spinal Atrophy, X-Linked |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000607739 | darolutamide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Goserelin | Drug | Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks. |
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BOR will be defined as the best response recorded from the start of protocol treatment based on RECIST version 1.1 |
| Up to 13 month |
| Disease Control Rate (DCR) | DCR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD for at least 6 weeks based on RECIST version 1.1. | Up to 13 month |
| Clinical Benefit Rate (CBR) | CBR will be 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. | Up to 13 month |
| Clinical Benefit Duration (CBD) | CBD will be defined the period starting from the date of enrollment (start of treatment) and ending on the earlier of the date of determination of progression, the date of death from any cause, or the end of the study period. | Up to 13 month |
| Progression-Free Survival (PFS) | PFS will be 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. | Up to 13 month |
| Overall Survival (OS) | OS will be defined as the time from the date of the initial dose of study intervention to the date of the participant's death | Up to 13 month |
| Adverse events | All adverse events, adverse events with undeniable causal relationship to the investigational drug, severe adverse events (SAEs) and SAEs with undeniable causal relationship to the investigational drug will be evaluated based on CTCAE version 5.0 | Up to 30 days after the last dose |
| Quality of Life assessed using the EuroQol-5Dimention-5Level (EQ-5D-5L) questionnaire | Changes from baseline to each time point in health-related quality of life will be measured using the European Quality of Life Five Dimension Five Level Scale Assessment Questionnaire (EQ-5D-5L). The EQ-5D-5L consists of a description and a health assessment. The health description consists of five dimensions (mobility, self-care, normal activities, pain / discomfort, and anxiety / depression), with each dimension identifying five levels of severity [best (1) - worst (5)]. Health assessment is assessed using a visual analogue scale (VAS)([worse (0) - better (100)]. | Up to 30 days after the last dose |
| Darolutamide monotherapy group: ORR assessed by an Independent Review Committee | The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee | Up to 13 month |
| Darolutamide and Goserelin combination therapy group: ORR assessed by investigators | The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators | Up to 13 month |
| Comparison of androgen receptor (AR) test results in Darolutamide and Goserelin combination therapy group | Comparison of AR test results between each institutional and a central assessment | Baseline |
| Positivity of Ki-67 in Darolutamide and Goserelin combination therapy group | The proportion of patients who have high expression of Ki-67 by a central assessment | Baseline |
| Chiba |
| Chiba |
| 260-8677 |
| Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | Fukuoka | 810-8563 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| The Jikei University Hospital | Tokyo | Tokyo | 105-0003 | Japan |
| Tokyo Medical And Dental University Hospital | Tokyo | Tokyo | 113-8519 | Japan |
| Tokyo Medical University Hospital | Tokyo | Tokyo | 160-0023 | Japan |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |