EUCTR2015-005177-21-FR进行中（未招募）不适用
Dose-Finding of Propranolol in combination with metronomic fixed oral cyclophosphamide based on Bivariate efficacy-tolerability outcome in patients with locally advanced or metastatic angiosarcoma : A collaborative and innovative phase I-II sequential trial by the French Sarcoma Group (GSF/GETO) - PROPAN01
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Man or woman 18 years old or over and a World Health Organization performance status score = 2 PS;
- •-Adolescents > 15 years with body surface > 1.6 m2
- •Subject with an Histologically proven angiosarcoma, reviewed by an independent pathologist, with metastasis or locally advanced stage not amenable to radiotherapy or curative-intent surgery after multidisciplinary decision making;
- •Subject with Prior systemic treatment with paclitaxel or doxorubicin;
- •Subject with angiosarcoma with an indication and prescription of treatment by oral cyclophosphamide after multidisciplinary decision making;
- •Subject with no more than two prior lines of chemotherapy (whatever the indication);
- •Subjects with absence of brain or meningeal metastasis;
- •Subject with at least one lesion measurable according to the RECIST, version 1.1;
- •Subject with neutrophil count =1,000/mm3, platelet count = 100 000/mm3, hemoglobin level = 8 g/Dl, liver transaminases = 1.5 x ULN, total bilirubin = 1.5 x ULN, serum creatinine = 1.5 x ULN, and amylase and lipase = 1.5 x ULN.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Minors or pregnant or breast-feeding women.
- •Subject with a contraindication to propranolol (ie cardiogenic shock; sinus bradycardia and greater than first-degree block; Chronic Obstructive Pulmonary Disease and bronchial asthma; patients with known hypersensitivity to Propranolol; assessed by cardiovascular and pulmonar history and examinations including blood pressure, ECG; untreated Pheochromocytoma, Congestive heart failure not controlled by treatment, Prinzmetal’s angina)
- •Subject with Severe Raynaud Phenomena or Raynaud Disease
- •Subject with Prior systemic treatment with Cyclophosphamide as 1st or 2nd line
研究者
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