KCT0009586尚未招募Unknown
An open label, multicenter Biomarker-driven Phase II Study of Combination Treatment with Darolutamide, Goserelin, and Docetaxel for Patients with Advanced Salivary Gland Cancer (SGC)
试验速览
- 阶段
- Unknown
- 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
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. histologically confirmed salivary gland cancer
- •2. (CT, MRI, X-ray) Local progressive or metastatic diseases that have been proven to have recurred and progressed when comparing the findings of imaging tests taken within the last 9 months with those taken immediately before registration in this study. (** Disease progression should be documented in accordance with RECIST v1.1)
- •3. Surgery, radiation, or combination therapy for therapeutic purposes can be expected to cure the disease
- •a person with a disease that is not present
- •4. Subjects with positive (=40%) Androgen receptor (AR) expression by Immunohistochemistry (IHC) technique in salivary gland cancer tissue
- •(**Other molecular diagnostics, including FISH and NGS, are also acceptable if negative (0%) at IHC)
- •5. Presence of at least one measurable target lesion as of RECIST 1.1
- •6. the age of 19 years or older
- •7. ECOG performance status 0, 1
- •8. Subjects previously treated with chemotherapy, topical therapy are allowed if their toxicity was resolved to grade 1 or less at trial registration and the last treatment was performed at least 4 weeks prior to the first dose of the clinical trial drug.
- •9. Patients with appropriate major organ functions identified
- •Absolute neutrophil number (ANC) = 1500/ µL
- •Platelets =100,000/µL
- •Hemoglobin (Hb) = 9.0 g/dL
- •Serum creatinine = 1.5 times normal upper limit (ULN) or calculated ccr ? 60 mL/min
- •1.5 times serum bilirubin = normal upper limit (ULN)
- •• PT and aPTT = 1.5 X ULN
- •AST, ALT = 3.0 times normal upper limit (ULN) (with or without liver metastasis)
- •10. A patient who is willing and adaptable to the test plan during the trial period
- •11. Sign a written consent form prior to participation in the examination and take the examination without any disadvantage at any time
- •Subjects who understand that they have the right to withdraw their consent from participation
排除标准
- •1. Patients with a history of gonadotropin Releasing Hormone (GnRH) agonist treatment, such as flutamide, nilutamide, cyproterone acetate, enzalutamide, apalutamide, etc., or first or second-generation AR inhibitors or goserelin acetate, including darolutamide (** However, bicalutamide or tamoxifen treatment is allowed)
- •2. Patients with a history of previous treatment with abiraterone acetate or alternonel, a CYP17 enzyme inhibitor
- •3. Patients who have used oral ketoconazole for more than 28 days in the past
- •4. Subjects without measurable lesions
- •5. Subjects who have undergone chemotherapy, radiotherapy or surgery within 4 weeks prior to the first dose of the clinical trial drug, except for conventional radiotherapy for nontarget lesions (which took place within 2 weeks prior to the first dose of the clinical trial drug)
- •6. Subjects with gastrointestinal disease, intestinal obstruction or urgent obstruction, and recent active upper gastrointestinal bleeding that may impair clinical drug use and absorption
- •7. a pregnant or nursing woman
- •8. Subjects of childbearing age who have not been tested for pregnancy at baseline or have obtained a positive result. (Postmenopausal women with amenorrhea period of 12 months or longer are considered unlikely to become pregnant.)
- •9. Men or women of childbearing age who are not willing to use contraceptive methods during the trial
- •10. Subjects with a history of other malignancies within the last 3 years, except for cured skin basal cell carcinoma and cervical intraepithelial carcinoma
- •11. Subjects with a history of uncontrolled seizures, central nervous system disorders, or mental disorders deemed clinically significant by the examiner, which may interfere with the understanding of written consent or affect compliance with the administration of the trial drug
- •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 have received organ transplants requiring immunosuppressive therapy
- •14. Subjects who are expected to have severe hypersensitivity to Darolutamide and goserlin acetate and docetaxel principal components or excipients
- •15. High blood pressure not controlled by medication (systolic/relaxor blood pressure =160/95mmHg)
- •16. Patients with active or symptomatic viral hepatitis and chronic epilepsy
- •17. a patient with a history of pituitary or adrenal abnormalities
- •18. Uncontrolled brain, spinal cord metastases
- •19. Subjects who received a live/weakened vaccine within 30 days of the first dose in the trial
- •20. uncontrolled pleural fluid, pericardial fluid or ascites
研究者
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