Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial
| Registry | NCT06348264 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 37 (Estimated) |
| Sponsor | Peking University First Hospital (Other); collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd., Beijing Biote Pharmaceutical Co.,Ltd |
| Conditions | Salivary Gland Neoplasm Duct |
| Interventions | Rezvilutamide, Leuprolide Acetate (Drug) |
| Dates | start 2024-10-10, primary completion 2029-03-30 (estimated), completion 2031-03-30 (estimated), first posted 2024-04-04, last updated 2025-09-23 |
| Locations | 2 sites in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Rezvilutamide plus LHRHa | Experimental | Drug: Rezvilutamide; Drug: Leuprolide Acetate | Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing, Beijing Municipality | China | Recruiting |
| Peking University School and Hospital of Stomatology | Beijing, Beijing Municipality | China | Recruiting |