EUCTR2010-024621-20-NL进行中（未招募）不适用
First International Randomized Study in MAlignant Progressive Pheochromocytoma and Paraganglioma - FIRSTMAPPP
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
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
- •-Diagnosis of malignant PPGL,
- •-Metastatic disease not amenable to surgical resection
- •-Pre-treated or not
- •-Whatever the genetic status (sporadic or inherited)
- •-Evaluable disease according to RECIST 1.1 criteria
- •-ECOG performance status 0-2
- •-Life expectancy = 6 months as prognosticated by the physician
- •-Age = 18 years, no superior limit
- •-Adequate bone marrow reserve (Hb > 8, neutrophils = 1500/mm³ and platelets =80.000/mm³)
- •-Ability to comply with the protocol procedures
- •-Ability to take oral medication
- •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 74
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Large or small cell-poorly differentiated neuroendocrine carcinoma according to WHO 2000 classification
- •-History of prior malignancy,
- •-Severe renal or hepatic insufficiency
- •-Patients with cardiac events
- •-Hypertension
- •-Brain metastases
- •-Previous treatment with the drug under study. Prior systemic treatment with any tyrosine kinase inhibitors or anti VEGF angiogenic inhibitors.
- •-Major surgery for any cause or local radiotherapy within one month prior to visit 1
- •-Liver embolisation therapy within the last 3 months prior visit 1
研究者
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