KCT0007110尚未招募未知
Phase II study of darolutamide combined with goserelin in patients with androgen receptor expressing salivary gland carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Histologically confirmed salivary gland cancer.
- •2. Local progressive or metastatic disease that has been proven to recur or progression of the disease when comparing imaging findings taken within the last 9 months (CT, MRI, X-ray) with imaging findings immediately before registration.
- •(* Disease progression must be documented according to RECIST v1.1 criteria)
- •3. You can expect complete recovery with therapeutic purposes such as surgery, radiation, or combination therapy.
- •Those who don't have a disease.
- •4. Subjects identified as positive for androgen acceptor (AR) expression by immunohistochemistry (IHC) technique in salivary gland cancer tissue (including weak positives)
- •(*Other molecular diagnostic methods, including FISH and NGS, are also acceptable if negative (0%) is found in IHC)
- •5. Presence of at least one measurable target lesion for further evaluation based on RECIST 1.1 criteria
- •6. Age of 19 or older.
- •7. ECOG performance status 0, 1.
- •8. Subjects previously treated with chemotherapy and topical therapy are allowed if toxicity was resolved below grade 1 at the time of registration and the last treatment was performed at least 4 weeks prior to baseline evaluation.
- •9. Patients with appropriate major organ function identified
- •Absolute neutrophil (ANC) 1500 1500/µL
- •Platelets 100100,000/µL
- •Hemoglobin (Hb) 9 9.0 g/dL.
- •Serum creatinine ?????? 1.5 times the normal upper limit (ULN) or calculated ccr 60 60 mL/min.
- •Serum bilirubin ?????? 1.5 times the normal upper limit (ULN)
- •AST, ALT ?????? 3.0 times the normal upper limit (ULN) (regardless of liver transfer)
- •10. Patients who are willing and compliant with the test plan during the test period.
- •11. Sign a written consent form before participating in the test and take the test at any time without disadvantage.
- •Subject to understand that they have the right to withdraw consent from participation.
排除标准
- •1. In the past, first or second-generation AR inhibitors such as flutamide, nilutamide, cyprotonone acetate, enzalutamide, apalutamide, etc., including darolutamide, or gonadotropin releasing hormone (GnRH) patients with a previous history.
- •2. Patients with a history of being treated with abiraterone acetate or alternel, which is a CYP17 enzymeinhibitor, in the past.
- •3. Patients who used oral ketoconazole for more than 28 days in the past.
- •4. Those who don't have a lesion to measure.
- •5. (conducted within two weeks prior to registration of the examination) Subjects who received chemotherapy, radiation therapy, and other clinical medication within 4 weeks prior to test registration, except for conventional radiotherapy for non-target lesions.
- •6. Subjects with gastrointestinal diseases, intestinal obstruction or desperate obstruction that may hinder the use and absorption of clinical drugs, and recently active upper gastrointestinal bleeding.
- •7. Pregnant women or lactating women.
- •8. Subject to childbearing age who did not undergo pregnancy tests or obtained positive results at baseline. ( postmenopausal women with a nonmenopausal period of 12 months or more are considered to have no possibility of pregnancy.)
- •9. Men or women of childbearing age who are not willing to use contraceptive methods during the examination.
- •10. Subjects with a history of other malignant diseases within the past 5 years, except for cured skin basal cell carcinoma and cervical epithelial cancer.
- •11. Subjects with a history of uncontrolled seizures, central nervous system disorders, or mental disorders judged clinically significant by the tester, which may interfere with the understanding of written consent forms or affect compliance with test drug administration.
- •12. Subjects who have experienced clinically significant heart disease (e.g., congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia, etc.) or myocardial infarction within the past 12 months.
- •13. Subjects who received organ transplants requiring immunosuppressive therapy.
- •14. Subjects who are expected to have severe hypersensitivity to the main ingredients or adrenal siblings of Darolutamide and goselin acetate.
- •15. High blood pressure that is not controlled even by medication (reducing/relaxing blood pressure 1160/95 mmHg)
- •16. Patients with viral hepatitis and chronic liver disease accompanied by activity or symptoms.
- •17. Patients with a history of abnormal pituitary or adrenal function.
- •18. Uncontrolled brain and spinal cord metastasis.
- •19. Uncontrolled pleural fluid, pericardial fluid, or ascites.
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