Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma

Official title

Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial

Overview

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

• Drug Rezvilutamide
  Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.
• Drug Leuprolide Acetate
  The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.

Primary outcome measures

• 3-year disease-free survival (DFS) [Time frame: 36 months]

Secondary outcome measures (5)

• 3-year overall survival (OS) [Time frame: 36 months, 60 months]
• 3-year disease-specific survival (DSS) [Time frame: 36 months, 60 months]
• 3-year distant-metastatic free survival (DMFS) [Time frame: 36 months, 60 months]
• Adverse events [Time frame: 36 months]
• 5-year disease-free survival (DFS) [Time frame: 60 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Peking University First Hospital — Beijing
• Peking University School and Hospital of Stomatology — Beijing

Identifiers

NCT: NCT06348264 · SDC-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗