EUCTR2014-003774-16-FR进行中（未招募）1 期
Phase I/II dose-finding, safety and efficacy study of radium-223 dichloride (XOFIGO®) in renal cell carcinoma patients with bone metastases - EIFFE
A.R.T.I.C. (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie )0 个研究点开始时间: 2015年6月19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
- •Patients eligible for inclusion in this study have to meet the following criteria:
- •1.Histologically confirmed metastatic RCC with a clear cell component..
- •2.Bone metastases upon bone scan and MRI performed any time within period of 4 weeks prior to study entry, with at least one evaluable unidimensional bone lesion (i.e., =1 malignant tumour mass that can be accurately measured in at least 1 dimension = 10 mm on T1-weighted Magnetic Resonance Imaging [MRI]).
- •Group A: bone metastases (lymph nodes and/or adrenal metastases, and/or = 5 lung metastases of less than 1 cm each, are allowed) .
- •Group B: bone metastases AND visceral metastases upon MRI or CT-scan (according to revised RECIST 1.1 criteria).
- •3.Naïve patient (first line setting) or patient with disease progression on last therapy (second or third line setting).
- •4.Male or female, age =18 years at ICF signature time.
- •5.ECOG performance status of 0 or 1.
- •6.Good or Intermediate prognostic group according to the International Metastatic Database Consortium (IMDC).
- •7.At least 4 weeks from the end of a previous systemic treatment, if any, with resolution of all treatment-related toxicity according to NCI CTCAE Version 4.03 grade = 1 except for alopecia.
- •8.Palliative local treatment allowed if performed = 2 weeks prior to study entry for radiotherapy, cimentoplasty or minor surgery; = 4 weeks prior to study entry for major surgery.
- •9.Adequate organ function defined by the following criteria:
- •a.Absolute Neutrophils count (ANC) =1 500 cells/mm3
- •b.Platelets =100 000 cells/mm3
- •c.Haemoglobin = 9.0 g/dL
- •d.AST and ALT = 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT =5.0 x ULN
- •e.Total bilirubin = 1.5 x ULN
- •f.Serum creatinine = 1.5 x ULN or calculated creatinine clearance = 50 mL/min
- •g.Urinary protein < 2+ by urine dipstick. If dipstick is = 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours
- •h.Corrected calcium = 2.8 mmol/L.
- •10.Women of childbearing potential must have a negative serum pregnancy test within 7days prior to treatment initiation.
- •11.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment.
- •12.Willingness to comply with protocol requirements, including effective contraception during study treatment and for 6 months after last dose of study drug.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Poor prognostic group according to the IMDC.
- •2.Prior radiotherapy to = 40% of bone marrow, whole pelvic irradiation and/or prior isotope therapy whatever the isotope (any a- or ß-emitters).
- •3.Active secondary cancer including prior malignancy from which the subject has been disease-free for = 3 years (however, adequately treated superficial basal cell skin or cervical carcinoma in situ before 4 weeks prior to entry are eligible to the study).
- •4.Known brain or leptomeningeal involvement.
- •5.Other concurrent serious illness or medical conditions.
- •6.Uncontrolled hypertension.
- •7.Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure, or myocardial infarction within the last 6 months.
- •8.QTc interval (QTc) assessed by local device > 500ms in the 7 days prior to inclusion.
- •9.Biphosphonates, denosumab and/or vitamin D supplementation received within 2 weeks before the first injection of XOFIGO®.
- •10.Active infection requiring systemic antibiotic or anti-fungal medication.
- •11.Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
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