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Trial Title:
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
NCT ID:
NCT06348264
Condition:
Salivary Gland Neoplasm Duct
Conditions: Official terms:
Carcinoma, Ductal
Salivary Gland Neoplasms
Leuprolide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rezvilutamide
Description:
Rezvilutamide 240 mg (3*80mg tablets) will be administered orally once daily with or
without food.
Arm group label:
Rezvilutamide plus LHRHa
Intervention type:
Drug
Intervention name:
Leuprolide Acetate
Description:
The dose and frequency of administration will be consistent with the prescribing
information in prostate cancer patients.
Arm group label:
Rezvilutamide plus LHRHa
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueying Ren, MD
Phone:
+86 10 83572408
Email:
xy_ren1031@126.com
Facility:
Name:
Peking University School and Hospital of Stomatology
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofeng Shan, MD
Phone:
+86 10 82195390
Email:
kqsxf@263.net
Start date:
March 30, 2024
Completion date:
March 30, 2031
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Beijing Biote Pharmaceutical Co.,Ltd
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348264
