A single arm, multicenter, phase II trial of RAD001 as monotherapy in the palliative treatment of patient with locally advanced or metastatic transitional cell carcinoma after failure of platinum-based chemotherapy

Cliniques Universitaires St Luc0 个研究点目标入组 40 人开始时间: 2008年9月4日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- Patients histologically- orcytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation
•- Patient with documented disease progression after first-line platinum -based therapy
•- Patients with at least one measurable lesion as at baseline as per RECIST criteria
•- ECOG performance status of 0-2
•- Patients must be over 18 years old and must be able to give written informed consent
•- Patients with adequate bone marrow function, liver function and renal function
•- Patients must have an expected survival of at least 6 months
•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

•- Patients who have received more than 2 systemic treatment for their metastatic disease
•- Patients who received prior therapy with VEGF pathway inhibitor or other biological therapies at the exception of mTOR inhibitors
•- Patients who have previously received mTOR inhibitors
•- Patients with a known hypersensibility to RAD001 or other rapamycins or to its excipients
•- Patients with brain or leptomeningeal metastases
•- Patients receiving chronic systemic treatment with corticosteroïds or another immunosuppressive agent
•- Patients with known hitory of HIV seropositivity
•- Patients with an active, bleeding diathesis
•- Patients who have any severe and/or uncotrolled medical conditions or other conditions that could affect their participation in the study
•- Patients who have a history of another primary malignancy more than 5 years ago

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