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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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 at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Chiba University Hospital
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
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
Time frame: 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
Time frame: Up to 13 month
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.
Time frame: Up to 13 month
Best Overall Response (BOR)
BOR will be defined as the best response recorded from the start of protocol treatment based on RECIST version 1.1
Time frame: 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.
Time frame: 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.
Time frame: Up to 13 month
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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
...and 2 more locations
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)(\[worse (0) - better (100)\].
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline