Salivary Gland Neoplasm Duct
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC). The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years.
Interventions
DRUGRezvilutamide
Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.
DRUGLeuprolide Acetate
The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.
Sponsors
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Beijing Biote Pharmaceutical Co.,Ltd
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Histologically confirmed salivary duct carcinoma and stage III or IVa or IVb according to AJCC Cancer Staging Manual Eighth Edition * Completed SDC surgery, and adjuvant radiotherapy is planned or ongoing or has completed * Androgen receptor (AR) positive * White blood cell (WBC) ≥ 3.0 x 10\^9/L, Neutrophil count≥ 1.5 x 10\^9/L, Platelet count (PLT) ≥ 75 x 10\^9/L, Haemoglobin (Hb) ≥ 90 g/L * Serum creatinine (Cr) \< 1.5 x upper limit of normal(ULN) or creatinine clearance ≥ 50 ml/min. * Total bilirubin (TBIL) \< 1.5 x ULN, AST\< 2.5 x ULN, and ALT\< 2.5 x ULN * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, and ability to take oral medication * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 year after the end of study intervention administration * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Exclusion criteria
* Received prior anti-AR pathway therapy * Treatment with another investigational drug or chemotherapy within 6 months * History of hypothalamus or pituitary dysfunction * History of seizure * Clinically uncontrolled diseases, such as septic shock, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, clinically unstable arrhythmia, myocardial infarction (in the past 6 months) * Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated \> 5 years prior to study entry * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival (DFS) | 36 months | DFS is defined as the time from entry until disease recurrence or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival (OS) | 36 months, 60 months | OS is defined as the time from entry until death due to any cause |
| 3-year disease-specific survival (DSS) | 36 months, 60 months | DSS is defined as the time from entry until disease-specific death |
| 3-year distant-metastatic free survival (DMFS) | 36 months, 60 months | DMFS is defined as the time from entry until distant metastasis or death |
| Adverse events | 36 months | Evaluate adverse events utilizing CTCAE V5 |
| 5-year disease-free survival (DFS) | 60 months | DFS is defined as the time from entry until disease recurrence or death |
Countries
China
Outcome results
None listed