NL-OMON50857撤回2 期
A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas - CAAA601A32201 (NETTER-P)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •1. GEP-NET cohort: Presence of metastasized or locally advanced, inoperable
- •(curative intent), histologically proven, G1 or G2 (Ki-67 index <=20%), well
- •differentiated GEP-NET. PPGL cohort: presence of metastasized or locally
- •advanced, inoperable (curative intent), histologically proven PPGL.
- •2. Patients from 12 to < 18 years of age at the time of enrollment.
- •3. Expression of somatostatin receptors confirmed by a somatostatin receptor
- •imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake
- •observed in the target lesions more or equal to the normal liver uptake.
- •4. Performance status as determined by Karnofsky score >= 50 or Lansky
- •Play-Performance Scale score >= 50.
排除标准
- •Laboratory parameters:
- •Estimated creatinine clearance calculated by the Cockroft-Gault method < 70
- •Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L; platelets <75x109/L.
- •Total bilirubin >3 x ULN for age.
- •Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
研究者
相似试验
进行中（未招募）
1 期
Phase 2 study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs, pheochromocytoma and paragangliomasEUCTR2020-002951-39-PLAdvanced Accelerator Applications SA12
进行中（未招募）
1 期
Phase 2 study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs, pheochromocytoma and paragangliomassomatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomasMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10077559Term: Gastroenteropancreatic neuroendocrine tumour diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10034876Term: PheochromocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10073860Term: ParagangliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002951-39-PTAdvanced Accelerator Applications SA12
进行中（未招募）
1 期
Phase 2 study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs, pheochromocytoma and paragangliomassomatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomasMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10077559Term: Gastroenteropancreatic neuroendocrine tumour diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10034876Term: PheochromocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10073860Term: ParagangliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002951-39-SEAdvanced Accelerator Applications SA12
进行中（未招募）
1 期
Phase 2 study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs, pheochromocytoma and paragangliomassomatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomasMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10077559Term: Gastroenteropancreatic neuroendocrine tumour diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10034876Term: PheochromocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10073860Term: ParagangliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002951-39-ITAdvanced Accelerator Applications SA12
进行中（未招募）
1 期
Study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs and PPGLs.somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomasMedDRA version: 21.0Level: PTClassification code: 10052399Term: Neuroendocrine tumour Class: 100000004864MedDRA version: 20.0Level: LLTClassification code: 10077560Term: Gastroenteropancreatic neuroendocrine tumor disease Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10077559Term: Gastroenteropancreatic neuroendocrine tumour disease Class: 100000004864MedDRA version: 20.0Level: LLTClassification code: 10073860Term: Paraganglioma Class: 10029104MedDRA version: 20.1Level: LLTClassification code: 10034876Term: Pheochromocytoma Class: 10029104CTIS2023-507444-37-00Advanced Accelerator Applications11