An open-label, multicenter phase II study to examine the efficacy andsafety of everolimus as second-line therapy in the treatment of patientswith metastatic renal cell carcinoma - RECORD-4

ovartis Pharma Services AG0 个研究点目标入组 201 人开始时间: 2012年6月14日最近更新: 2016年2月8日

适应症

试验速览

暂无简介。

•- Advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) renal carcinoma that have previously progressed on or were intolerant to firstline therapy with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy
•- Prior nephrectomy (partial or total)
•- Patients with at least one measurable lesion at baseline as per the RECIST 1.0 criteria
•- Karnofsky Performance Status = 70%
•- Age = 18 years old
•Other protocol-defined inclusion criteria may apply.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 101

•- Patients who have received more than one prior treatment regimen for metastatic renal-cell carcinoma
•- Patients who have received adjuvant therapy for RCC
•- Patients who have previously received systemic mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus)
•- Patients with brain metastases
•- Patients within 4 weeks post-major surgery, open biopsy, or significant traumatic injury to avoid wound healing complications.
•- Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
•- Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
•Other protocol-defined exclusion criteria may apply.

发起方