EUCTR2010-020067-20-FR进行中（未招募）1 期
A multicentre phase II trial to determine the efficacy of RAD 001 (everolimus, Afinitor®) as second line therapy in patients with transitional cell carcinoma (TCC) of the urothelium which failed or progressed after first line chemotherapy. - AFINIVEST
Hôpital FOCH0 个研究点开始时间: 2010年6月18日最近更新:
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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
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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
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Patient Information and written informed consent form signed
- •2. Patient aged 18 years old or more
- •3. Histologically proven advanced transitional cell carcinoma of the urothelium,
- •4. Metatatic or inoperable locally advanced disease
- •5. Disease recurring or progressing after two lines of chemotherapeutic ageents, tah have urothelial cancer as a specific indication in their RCP (as for instance Javlor)
- •6. Previous chemotherapy or radiotherapy must have been stopped 30 days before first dose of study treatment and patients must have recovered from any serious side effects of treatment,
- •7. Except if contra-indicated, patients must have been treated with two lines of chemotherapy
- •8. Patients must have one measurable lesion defined by RECIST criteria not previously irradiated, assessed by conventional CT-scan or MRI performed < 30 days before first day of study drug administration,
- •9. Patients must have a performance Status < 2 on the Eastern Cooperative Oncology Group Scale ,
- •10.Adequate haematological function (ANC > 1.5 x 109/L; Platelets ³ 100 x 109/L and Hb ³ 8 g/dL),
- •11. Adequate hepatic function: total bilirubin £ 1.5 times the upper limit of normal (ULN), ASAT and ALAT £ 2.5 x ULN or £ 5 x UNL in presence of liver metastase,
- •12. Adequate renal function: calculated creatinine clearance =40 ml/min according to Cockcroft and Gault formula,
- •13. Adequate lipid profile: total cholesterol < 300 mg/dL and triglycerides < 200 mg/dL.
- •14. Women and men with reproductive potential must use medically acceptable contraceptive method,
- •15. Patients must be affiliated to the French National Health Insurance System
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with radiotherapy involving more than 25 % of marrow producing area
- •2. Concurrent anti-cancer treatment
- •3. Prior treatment on RAD001
- •4. Symptomatic brain metastases
- •5. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as :
- •- unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction = 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents = 6 months before study treatment start
- •- severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- •- poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN
- •- any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study
- •- nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study treatment.
- •- liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis.
- •6. Patients receiving chronic systemic treatment with corticosteroids (dose of = 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable .
- •7. Patients with a known history of HIV seropositivity.
- •8. Treatment with anticoagulant agent with warfarin or unfractionated heparin; patients requiring anticoagulation may be entered after successful conversion to low molecular weight heparin.
- •9. Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, incidental PT2 prostate cancer found on a radical cystoprostatectomy material; or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months.
- •10. Pregnant women, women who are likely to be pregnant or are breastfeeding,
- •11. Hypersensitivity to the study drug, other derivatives of rapamycinen notably sirolimus and temsirolius, and/or to any the encipients notably lactose and galactose.
- •12. Patients with galactos intolerance, Lapp lactase deficiency or a glucose galactose malapsortion syndrome
- •13. Individuals deprived of liberty or placed under the authority of a tutor.
- •14. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.
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