NCT02961491Approved For Marketing不适用
Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 3
研究概览
简要总结
The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).
详细描述
MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect additional safety data.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent/assent and comply with protocol requirements
- •Documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by histology or other supportive data (e.g. abnormal MIBG diagnostic study or elevated tumor markers)
- •Ineligible for curative surgery for PPGL
- •Failed a prior therapy for PPGL or have no alternative indicated therapy available
- •Have definitive tumor avidity confirmed by the AZEDRA dosimetry dose
- •Life expectancy of at least 6 months per physician
排除标准
- •Pregnant or nursing females
- •Men or women of childbearing potential and unwilling to use a medically acceptable form of contraception from time of consent until 6 months following last therapeutic dose of AZEDRA
- •Active CNS lesions by CT/MRI within 3 months of informed consent
- •NYHA class IV heart failure, unstable angina pectoris or clinically significant cardiac arrhythmia that poses a risk of syncope or cardiac arrest
- •Prior systemic radiotherapy resulting in marrow toxicity within 3 months of first AZEDRA therapeutic dose
- •Prior iobenguane I 131 therapeutic exposure within 12 weeks of the first planned therapeutic dose
- •Prior administration of whole-body radiation therapy within 12 weeks of the first planned therapeutic dose
- •Prior external beam radiotherapy to > 25% of bone marrow
- •Prior chemotherapy or investigational compound and/or device within 30 days of the dosimetry dose
- •Other active malignancy requiring additional treatment except for superficial cutaneous neoplasms
- •Karnofsky Performance Status < 60
- •Clinically significant laboratory abnormalities prior to dosing as listed in the protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal dysfunction)
- •Medical history of AIDS/HIV+
- •Active chronic alcohol abuse, chronic liver disease (not including liver metastases), hepatitis A, B, or C
- •Known allergy to iobenguane that has required medical intervention
- •Receiving a medication which inhibits tumor uptake of iobenguane I 131
- •Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject
研究者
研究点 (3)
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