EUCTR2010-024515-13-NL进行中（未招募）1 期
Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.
VU University Medical Center0 个研究点开始时间: 2011年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1. Patients with histologically or cytologically confirmed clear-cell mRCC with progressive disease and not amenable to or progressive on or within 6 months of stopping treatment with a VEGF receptor tyrosine kinase inhibitor (sunitinib (or pazopanib) ± sorafenib).
- •2. Prior therapy with cytokines (i.e. IL-2, interferon) and/or VEGF-ligand inhibitors (i.e. bevacizumab) is permitted.
- •3. Patients with brain metastases are eligible if they have been stable for at least two months post-radiation therapy or surgery.
- •4. Aged 18 years or older.
- •5. No other current malignant disease, except for basal cell carcinoma of the skin.
- •6. WHO performance status 0-2.
- •7. Life expectancy of at least 12 weeks.
- •8. Adequate hematologic function: ANC = 1.5 x 109/L, platelets = 100 x 109/L, Hb = 6.0 mmol/L.
- •9. Adequate hepatic function: serum bilirubin = 1.5 x ULN, ALT and AST = 2.5 x ULN (or = 5 times ULN if liver metastases are present).
- •10. Adequate renal function: calculated creatinine clearance = 50 ml/min.
- •11. Measurable or evaluable disease as defined by RECIST 1.1.
- •12. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test.
- •13. Signed informed consent.
- •14. Able to receive oral medication.
- •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. Patients currently receiving chemotherapy, immunotherapy, or radiotherapy or who have received these = 4 weeks prior to visit 1. The wash-out period for sunitinib or sorafenib is at least 2 weeks from the first dose of the study medication.
- •2. Known human immunodeficiency virus (HIV) or other major immunodeficiency.
- •3. Immunosuppressive agents within 3 weeks of study entry, except for low dose corticosteroids when given for disorders such as rheumatoid arthritis, asthma, or adrenal insufficiency. Topical or inhaled corticosteroids are permitted.
- •4. Patients with an active bleeding diathesis or on oral anti-vitamin K medication.
- •5. Patients with untreated CNS metastases with clinical symptoms or who have received treatment for CNS metastases within 2 months of study entry. Patients with treated CNS metastases, who are neurologically stable and off of corticosteroids for more than 2 months prior to study entry are eligible to enter the study.
- •6. Active infection or serious intercurrent illness, except asymptomatic bacteriuria.
- •7. Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
- •8. Macroscopic hematuria
- •9. Prior therapy with mTOR inhibitors.
- •10. Known hypersensitivity to everolimus or other rapamycins (sirolimus/temsirolimus) or to its excipients.
- •11. Pregnant or nursing women, or women who were of childbearing potential and who were not utilizing an effective contraceptive method. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. Men with partners of childbearing potential not using an effective method of contraception. (Use of effective contraceptives must continue for 3 months after the last dose of everolimus).
- •12. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance.
- •13. Uncontrolled diabetes as defined by fasting serum glucose > 2 ULN, severely impaired lung function.
- •14. Cirrhosis/chronic active hepatitis/chronic persistent hepatitis, history of HCV infection (for hepatitis screening indications see section 3.3).
- •15. Drug or alcohol abuse.
- •16. Any other major illness that, in the investigator’s judgment, substantially increased the risk associated with the subject’s participation in the study.
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