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Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
- - 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 lactationTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Rezvilutamide plus LHRHa
Participants will receive rezvilutamide in combination with a 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Peking University First Hospital
Beijing, Beijing, 100034
Site Contact
Xueying Ren, MD
[email protected]
+86 10 83572408
Status
Recruiting
Address
Peking University School and Hospital of Stomatology
Beijing, Beijing,
Site Contact
Xiaofeng Shan, MD
[email protected]
+86 10 82195390
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