EUCTR2011-003416-23-DE
进行中（未招募）
1 期
An open label, single arm trial to evaluate patients with metastatic renal cell carcinoma treated with everolimus after failure of first line therapy with sunitinib or pazopanib - SUNPAZ
ovartis Pharma GmbH0 个研究点2011年12月15日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- metastatic renal cell carcinoma
- 发起方
- ovartis Pharma GmbH
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
- •2\.Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
- •3\.Patients scheduled for treatment with everolimus (Afinitor®).
- •4\.Patients with at least one measurable lesion at baseline as per RECIST\-criteria version 1\.1\.
- •5\.Patients with ECOG PS 0\-1\.
- •6\.Absolute neutrophile count \= 1\.5 x 109/L, platelets \= 100 x 109/L, Hb \> 9 g/dL (5\.6 mmol/l).
- •7\.serum bilirubin: \= 1\.5 x ULN, ALT and AST \= 2\.5x ULN. Patients with known liver metastases: AST and ALT \= 5x ULN.
- •8\.serum creatinine \= 2\.5 x ULN.
- •9\.Urine protein of \< 2\+ in dip stick testing.
- •10\.Patients able to give written informed consent.
排除标准
- •1\.Patients who have received \>1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
- •2\.Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
- •3\.Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
- •4\.Patients within 4 weeks post\-major surgery (e.g. intra\-thoracic, intra\-abdominal or intrapelvic), open biopsy or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device 7 days prior to study entry.
- •5\.Patients who have had radiation therapy within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start.
- •6\.History or clinical evidence of central nervous system (CNS) metastases. Subjects who have previously treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
- •oare asymptomatic
- •ohave had no evidence of active CNS metastases for \= 3 months prior to enrolment (inactive/controlled CNS metastases are allowed)
- •ohave no requirement for steroids or enzyme\-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
- •7\.Patients in anticipation of the need for major surgical procedure during the course of the study.
结局指标
主要结局
未指定
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