Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B
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).
• 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