RAPTOR: A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer - RAPTOR

OVARTIS FARMA0 个研究点目标入组 60 人开始时间: 2009年7月3日最近更新: 2015年7月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: OVARTIS FARMA
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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) Age ≥ 18 years old 2) Patients with histological diagnosis of metastatic papillary renal cell carcinoma, type I or II, centrally confirmed (relevant slides and blocks - if available - must be sent for central reading within one month from enrollment: if this is not feasible the patient cannot be considered eligible) 3) Patients with at least one measurable lesion as at baseline as per RECIST criteria 4) Patients with an ECOG performance status of ≤ 1 5) Adequate bone marrow function as shown by: ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hb >9 g/dL. 6) Adequate liver function as shown by: serum bilirubin: ≤ 1.5 x ULN, INR< 1.3 (or <3 on anticoagulants), ALT and AST ≤ 2.5x ULN. For patients with known liver metastases: AST and ALT ≤ 5x ULN. 7) Adequate renal function as shown by: serum creatinine ≤ 2.0 x ULN. 8) Life expectancy ≥ 3 months 9) Fasting serum cholesterol ≤200 mg/dL or ≤5 mmol/L and fasting triglycerides ≤ 200 mg/dL. NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. 10) Women of childbearing potential must have had a negative urine pregnancy test within one week prior to the administration of the study treatment start. 11) Patients who give a written informed consent obtained according to local guidelines.
•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

排除标准

•1) Patients who had radiation therapy within 28 days prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start). 2) Patients who have received any prior systemic treatment for their metastatic RCC, such as sunitinib, sorafenib, and bevacizumab. 3) Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus). 4) Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients. 5)Patients with uncontrolled central nervous system (CNS) metastases. 6) Patients receiving chronic systemic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable, as well as opotherapy after bilateral adrenal gland removal. 7) Patients with a known history of HIV seropositivity. 8) Patients with autoimmune hepatitis. 9) Patients with an active, bleeding diathesis. 10) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study 11) Patients who have a history of another primary malignancy and off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix. 13) Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable. 13) Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. 14) Patients unwilling or unable to comply with the protocol.

研究者

发起方

OVARTIS FARMA

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