EUCTR2010-022589-29-GB进行中（未招募）1 期
Investigation of pathways regulating cell survival and early antiangiogenic response to single agent Everolimus or Rapamycin in renal cancer - Effects of mTOR Inhibition in renal cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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.Localised or metastatic renal cell cancer, any histological subtype, suitable for repeat sampling. Prior histological proof is not required, but scan appearances of newly diagnosed patients should be consistent with localised or metastatic RCC.
- •2.Age >=18 years.
- •3.ECOG performance status 0-2
- •4.Life expectancy >3 months
- •5.Either: scheduled for biopsy and nephrectomy, or metastatic disease, suitable for 2 CT-guided biopsies, including accessible deposits >2cm in soft tissue or bone.
- •6.Untreated or previously treated with systemic therapy including multi-kinase inhibitor (eg sunitinib, sorafenib), immunotherapy (eg interferon) or experimental therapy. Radiotherapy is acceptable provided lesion chosen for biopsy is outside the irradiated field.
- •7. Able to give written informed consent and cooperate with protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Clinical or CT scan features inconsistent with RCC unless pathologically confirmed.
- •2.Uncontrolled brain metastases.
- •3.Radiotherapy, major surgery, significant traumatic injury, systemic anti-cancer therapy (including immunotherapy, kinase inhibitor or experimental therapy) during the four weeks prior to starting study treatment.
- •4.Previous treatment with Rapamycin or Rapalogue (eg Everolimus, Temsirolimus).
- •5.Current or recent (within 10 days of Rapamycin) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
- •6.History or evidence of inherited bleeding diathesis or coagulopathy with risk of bleeding.
- •7.Uncontrolled diabetes mellitus (HbA1c >8%).
- •8.Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (MI) (=6 months before enrolment) unstable angina, CHF NYHA Class =II study, cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
- •9.Non-healing wound, active peptic ulcer or bone fracture.
- •10.Known hypersensitivity to Rapamycin and any of its excipients.
- •11.Other psychological, social or medical condition, physical examination finding or laboratory abnormality that the Investigator considers would make the patient a poor study candidate, or could interfere with protocol compliance or the interpretation of results.
- •12.Co-administration of Rapamycin with strong inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin, rifabutin). Low dose corticosteroids are permitted.
研究者
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