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

Peking University

Status and phase

Enrolling

Phase 2

Conditions

Salivary Gland Neoplasm Duct

Treatments

Drug: Leuprolide Acetate

Drug: Rezvilutamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06348264

SDC-1

Details and patient eligibility

About

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.

Enrollment

37 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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