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 个研究点开始时间: 2011年12月15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 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.
- •11.Age =18 years old.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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.
- •8.Patients with a serious non-healing wound, ulcer or bone fracture.
- •9.Patients with a history of seizure(s) not controlled with standard medical therapy.
- •10.Patients receiving chronic systemic treatment with corticosteroids (dose of >10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
- •11.Severely impaired lung function with a resting 02-saturation that is 88% or less on room air.
- •12.Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
- •13.Impaired liver function classified as Child-Pugh class A, B, or C.
- •14.Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis.
- •15.Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
- •16.Patients with positive history of severely impaired renal function or prior diagnosis of renal failure or proteinuria.
- •17.Patients with a known history of HIV seropositivity.
- •18.Patients with active bleeding.
- •19.Patients who have any severe and/or uncontrolled medical conditions that could affect their participation in the study, e.g. uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/ or diastolic blood pressure >90 mmHg.
- •20.Patients who have a history of another primary malignancy and of treatment for = 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) or prostate (T1 - T2).
- •21.Female patients who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)), or adults of reproductive potential who are not using effective birth control methods (Pearl Index <1). If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives that do not contain estrogen are acceptable for female patien
研究者
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