NCT04276597撤回2 期
A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.
Excel Diagnostics and Nuclear Oncology Center1 个研究点 分布在 1 个国家开始时间: 2020年3月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Assessment of the overall response rate
研究概览
简要总结
Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.
The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Known hypersensitivity to any of the excipients of Lu-177 DOTATOC.
- •Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to treatment.
- •Subjects with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up
- •Any subject who is taking concomitant medications that decrease renal function (such as aminoglycoside antibiotics).
- •Female subjects who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 67 days (more than 10 half-lives of 177Lu after the last treatment, or male subjects who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 67 days after the last treatment.
- •Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
- •Indication for surgical lesion removal with curative potential
- •Planned (for the period of study participation): chemotherapy, immunotherapy, radiation therapy (unless regional for pain relief) chemo-embolization, bland embolization, radio-embolization, treatment with cyclosporine-A.
- •Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrolment
- •Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological agent for less than 5 half-lives; and (3) radiation therapy (except regional for pain relief) for less than 6 weeks prior to study enrolment,
- •Uncontrolled congestive heart failure; subjects suspected of having this condition need to show ejection fraction of > 35% as determined by MUGA scan.
- •Glomerular Filtration Rate (GFR) < 35 mL/min
- •Subjects with prior peptide receptor radionuclide therapy (PPRT).
研究组 & 干预措施
Lu177 DOTATOC treatment
Experimental
4 doses of 200mCi 177Lu- DOTATOC PRRT
干预措施: 177Lu-DOTATOC (Drug)
结局指标
主要结局
Assessment of the overall response rate
时间窗: 12 monts
determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI
次要结局
- Progression Free Survival (rPFS) in subjects receiving 4 cycles of therapy Monitoring of the changes in quality of life (QOL) through assessment of ECOG performance status and a QOL subject questionnaire.(12 months)
研究者
研究点 (1)
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