PAZOBONE: First line treatment with Pazopanib in untreated metastatic renal cell carcinoma patients with bone involvement - PAZOBONE

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI0 个研究点目标入组 88 人开始时间: 2020年11月4日最近更新: 2020年11月9日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
入组人数: 88

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

•- Written informed consent
•- Age = 18 and = 80 years
•- ECOG Performance Status: 0-1-2
•- Life expectancy =24 weeks
•- Diagnosis of predominantly clear cell RCC
•- Risk score (Heng criteria): favorable or intermediate
•- No previous systemic treatment for Renal Cell Carcinoma
•- Documented metastatic disease (CT scan or MRI) with at least two bone metastasis (non pretreated with radiotherapy). Lesions could be measurable or not according with RECIST criteria v.1.1.
•-Laboratory requirements: Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, and Haemoglobin =10g/dL; Total bilirubin =1.5 time the upper-normal limits (UNL) of the Institutional normal values except for patients affected by Gilbert’s syndrome; AST (SGOT) and/or ALT (SGPT) =2.5 x UNL, or =5 x UNL in case of liver metastases; alkaline phosphatase =2.5 x UNL, =5 x UNL in case of liver metastases, =10 x UNL in case of bone metastases
•- Patients should be compliant to study protocol procedures
•- Patients could receive a bone targeted agents after the first two cycles of Pazopanib treatment; the preferred drug is denosumab (due to best renal safety)
•- Patients that will receive bone targeted agents must have baseline dental scan and dental examination (and after every 6 months)
•- Patients of childbearing age should use contraceptive methods during the study
•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 61
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 27

排除标准

•- Previous systemic treatment for mRCC
•- Non-clear-cell histology
•- Poor prognosis as defined by Heng criteria
•- History of malabsorption syndrome
•- Pregnant or breastfeeding women
•- Concomitant cardiac disorders: cardiac failure NYHA> 2; Acute coronary syndrome or myocardial infarction or severe or unstable angina within the last 6 months as well as uncontrolled hypertension (= 160/90)
•- Uncontrolled diabetes
•- Patients with single bone lesion that could receive curative treatment (radiotherapy or surgery)
•- Known central nervous system (CNS) metastases other than stable, treated brain metastases. Subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging for at least 3 months following prior treatment (radiotherapy or surgery)
•- Other cancer within the previous 5 years (except for in situ skin carcinoma, superficial bladder Ta, Tis, T1 and carcinoma of the cervix or every cancer with curative treatment within 5 years)
•- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or active hepatitis B or C
•- Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
•- Intravenous bisphosphonate or denosumab for bone metastasis, when started in the 3 months period before study inclusion
•- Planned radiation therapy or surgery to bone must be before 2 weeks to study enrollment
•- Radiotherapy during the study (except palliative radiotherapy)
•- Inability to swallow tablets or capsules

研究者

发起方

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

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