EUCTR2010-020664-38-GR进行中（未招募）1 期
Efficacy and safety of Bevacizumab/Temsirolimus combination after first-line Bevacizumab/IFN combination in advanced renal cell carcinoma
Hellenic Cooperative Oncology Group0 个研究点开始时间: 2010年10月4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
- •Adult patients (18th year of age completed).
- •Signed and dated written informed consent form prior to any procedures related to this protocol.
- •Histologically confirmed advanced clear cell renal cancer.
- •Measurable disease.
- •Failure of first line treatment of the combination bevacizumab and interferon A2 alpha.
- •Performace status 0-2, according to ECOG.
- •Satisfactory hematological parameters:
- •WBC >4000mm3
- •PLT >100000/mm3
- •ANC>1200/mm3
- •Hemoglobin>9,0 g/dL (can be achieved with red blood cell transfusion)
- •Satisfactory biochemical parameters:
- •Serum creatinine<2xULN
- •AST<2,5xULN
- •ALT<2,5xULN
- •Bilirubin<2xULN
- •(For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment).
- •(For female patients) Non-lactating women.
- •Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment
- •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
- •Prior treatment with mTOR inhibitor and/or TKI.
- •Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment.
- •Uncontrolled hypertension.
- •Active infection requiring systemic treatment within 4 weeks prior to enrollment.
- •Minor surgery (e.g. catheter replacement) within 2 days before enrollment.
- •Scheduled major surgery within the treatment period.
- •Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure.
- •Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment).
- •Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix).
- •History of non-healing wound including active gastric ulcer.
- •History of fistula in the last 6 months prior to enrollment.
- •History of gastrointestinal perforation.
- •Patient incapacity (for psychiatric or social reasons) to conform to the protocol.
- •History of hemorrhagic predisposition.
- •History of hypersensitivity to the medications under investigation.
- •Significant proteinuria.
- •Prior immunotherapy within 4 weeks prior to enrollment.
- •Prior radiation treatment within 2 weeks prior to enrollment.
- •Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4.
- •Concurrent participation in other interventional clinical trials with IMPs.
- •History of chronic interstitial lung disease.
研究者
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