EUCTR2008-008676-13-GB进行中（未招募）1 期
A Phase II Study Of Sunitinib And Low Dose Metronomic Cyclophosphamide In Advanced Renal Cell Cancer - SUN-CYCL (Sunitinib + Cyclophosphamide in RCC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patients with advanced renal cell carcinoma suitable for 1st line therapy with sunitinib
- •2. Histologically or cytologically confirmed advanced renal cell carcinoma
- •3. The presence of one or more clinically or radiographically measurable lesions
- •4. ECOG performance status 0 or 1
- •5. Life expectancy greater than 12 weeks
- •6. At least 14 days since major surgery and 7 days since skin/tumour biopsy
- •7. The capacity to understand the patient information sheet and the ability to provide written informed consent
- •8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •9. Male or female, age 18 or greater
- •10. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilized). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment
- •11. Serum aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 x upper limit of normal (ULN)
- •12. Total serum bilirubin =1.5 x ULN
- •13. Serum creatinine =1.5 x ULN
- •14. Haemoglobin =9.0 g/dL
- •15. Absolute neutrophil count =1.5 x 109/L
- •16. Platelets =100 x 109/L
- •17. Prothrombin time (PT) =1.5 x ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
- •2. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
- •3. Previous systemic treatment for metastatic renal cell carcinoma. Palliative radiotherapy to symptomatic disease sites is permitted
- •4. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment)
- •5. Malignancy other than the condition being treated or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
- •6. Use of any investigational drug within 30 days prior to screening
- •7. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •8. Uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
研究者
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